Study Testing Response Effect of KY1005 Against Moderate-... | NCT05131477 | Trialant
NCT05131477
Sponsor
Kymab Limited
Status
Completed
Last Update Posted
Jul 3, 2025Actual
Enrollment
390Actual
Phase
Phase 2
Conditions
Eczema
Atopic Dermatitis
Interventions
Amlitelimab
Placebo
Countries
United States
Australia
Bulgaria
Canada
Czechia
Germany
Hungary
Japan
Poland
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05131477
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KY1005-CT05/DRI17366
Secondary IDs
ID
Type
Description
Link
2021-000725-28
EudraCT Number
U1111-1271-1438
Other Identifier
Universal Trial Number
DRI17366
Other Identifier
Sponsor
Brief Title
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
Official Title
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis
Acronym
STREAM-AD
Organization
Kymab LimitedINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 13, 2021Actual
Primary Completion Date
Apr 26, 2023Actual
Completion Date
Feb 21, 2024Actual
First Submitted Date
Nov 11, 2021
First Submission Date that Met QC Criteria
Nov 11, 2021
First Posted Date
Nov 23, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 16, 2025
Results First Submitted that Met QC Criteria
Jun 17, 2025
Results First Posted Date
Jul 3, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 24, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 3, 2025Actual
Last Update Submitted Date
Jun 17, 2025
Last Update Posted Date
Jul 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kymab LimitedINDUSTRY
Collaborators
Name
Class
Sanofi
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Detailed Description
Not provided
Conditions Module
Conditions
Eczema
Atopic Dermatitis
Keywords
KY1005
Monoclonal Antibody
Atopic Dermatitis
Atopic Eczema
OX40L
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
390Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
250mg (500mg Loading Dose) KY1005
Experimental
Every 4 weeks
Drug: Amlitelimab
250mg (No Loading Dose) KY1005
Experimental
Every 4 weeks
Drug: Amlitelimab
125mg KY1005
Experimental
Every 4 weeks
Drug: Amlitelimab
62.5mg KY1005
Experimental
Every 4 weeks
Drug: Amlitelimab
Placebo
Placebo Comparator
Every 4 weeks
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Amlitelimab
Drug
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
125mg KY1005
250mg (500mg Loading Dose) KY1005
250mg (No Loading Dose) KY1005
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
AD involvement of 10% or more of body surface area (BSA) at Baseline.
Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of ≥4.
Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.
Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
Able to complete patient questionnaires.
Able and willing to comply with requested study visits/telephone visits and procedures.
Able and willing to provide written informed consent.
For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.
Exclusion Criteria:
Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Weight <40 kg or >150 kg at Baseline.
Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit.
Concurrent participation in any other clinical study, including non-interventional studies.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Reich A, Blauvelt A, Weidinger S, Shi VY, Katoh N, Lynde C, Gao X, Armstrong NM, Bernigaud C, Rahawi K. A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):605-616. doi: 10.1007/s13555-025-01609-6. Epub 2025 Dec 8.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
The study was performed in 2 parts: Part 1 for all population (baseline to Week 24) for efficacy and safety and Part 2 for Part 1 Responders (Week 24 to Week 52 for efficacy and Week 24 to Week 68 for safety). Responders are defined as participants who achieved ≥EASI 75 and/or IGA 0/1 at Week 24.
Recruitment Details
This study started in December 2021 and ended in February 2024. An individual participant was part of this study for about 1 year and 5 months. The study took place at 100 sites in 12 countries. Up to 350 participants (approximately 70 participants per treatment group) were planned to be enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Placebo
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to week 16 and week 24
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to weeks 2,4, 8,12,16, 20 and 24
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Baseline to weeks 2, 4, 8,12,16,20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Baseline to weeks 4, 8, 12, 16, 20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Absolute Change in Affected BSA From Baseline (Part 2)
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Affected BSA From Baseline (Part 1)
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Percentage Change in Affected BSA From Baseline (Part 2)
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Baseline to weeks 4, 8, 12, 16, 20, & 24
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Baseline to weeks 2, 8, 16, 20, & 24
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Baseline to weeks 16, & 24
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Baseline to weeks 24, 36 & 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Baseline to weeks 16, & 24
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Baseline to weeks 24, 36 & 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Baseline to weeks 8 16, 20, & 24
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Baseline to weeks 8, 16, 20, & 24
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Week 24 to week 52
Incidence Rate of Loss of EASI 75 (Part 2)
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Week 24 to week 52
Incidence Rate of Loss of IGA 0/1 (Part 2)
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Week 24 to week 68
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Baseline through week 24
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Week 24 through week 68
Percentage of Participants With Treatment-emergent ADA (Part 1)
Baseline through week 24
Percentage of Participants With Treatment-emergent ADA (Part 2)
Baseline through week 68
Sacramento
California
95816-3370
United States
Investigative Site Number: 1006
Boca Raton
Florida
33428
United States
Investigative Site Number: 1001
Clearwater
Florida
33756-3424
United States
Investigative Site Number: 1019
Coral Gables
Florida
33134-2950
United States
Investigative Site Number: 1007
Miami
Florida
33176-2264
United States
Investigative Site Number: 1013
Tampa
Florida
33615-3816
United States
Investigative Site Number: 1004
Savannah
Georgia
31406-2668
United States
Investigative Site Number: 1010
Clarksville
Indiana
47129-2201
United States
Investigative Site Number: 1015
Indianapolis
Indiana
46250-2041
United States
Investigative Site Number: 1021
Louisville
Kentucky
40241
United States
Investigative Site Number: 1011
Towson
Maryland
21204-7448
United States
Investigative Site Number: 1014
Beverly
Massachusetts
01915-1666
United States
Investigative Site Number: 1012
Troy
Michigan
48084-3536
United States
Investigative Site Number: 1005
Tulsa
Oklahoma
74136-7049
United States
Investigative Site Number: 1017
Portland
Oregon
97223-6683
United States
Investigative Site Number: 1009
Portland
Oregon
97239
United States
Investigative Site Number: 1003
Anderson
South Carolina
29621-2062
United States
Investigative Site Number: 1008
Murfreesboro
Tennessee
37130-2450
United States
Investigative site #1023
Mansfield
Texas
76063
United States
Investigative Site Number 3002
Carlton
3053
Australia
Investigative Site Number: 3003
East Melbourne
3002
Australia
Investigational Site Number: 3001
Parkville
3050
Australia
Investigative Site Number: 2004
Pleven
5800
Bulgaria
Investigative Site Number: 2005
Sofia
1431
Bulgaria
Investigative Site Number: 2006
Sofia
1592
Bulgaria
Investigative Site Number: 2003
Sofia
1612
Bulgaria
Investigative Site Number: 2002
Sofia
1784
Bulgaria
Investigative Site Number: 2001
Stara Zagora
6003
Bulgaria
Investigative Site Number: 1106
Markham
Ontario
L3P 1X2
Canada
Investigative site #1108
Niagara Falls
Ontario
L2H 1H5
Canada
Investigative Site Number: 1103
Ottawa
Ontario
K2C 3N2
Canada
Investigative Site Number: 1107
Waterloo
Ontario
N2J 1C4
Canada
Investigative Site Number: 1101
Windsor
Ontario
N8W 1E6
Canada
Investigative Site Number: 2105
Nový Jicín
Moravian-Silesian Region
741 01
Czechia
Investigative Site Number: 2102
Prague
Praha, Hlavní Mesto
108 00
Czechia
Investigative Site Number: 2103
Prague
Praha, Hlavní Mesto
130 00
Czechia
Investigative Site Number: 2108
Brno
South Moravian
602 00
Czechia
Investigative Site Number: 2106
Kutná Hora
284 01
Czechia
Investigative Site Number: 2104
Ostrava
702 00
Czechia
Investigative Site Number: 2209
Erlangen
Bavaria
91054
Germany
Investigative Site Number: 2202
Blankenfelde
Brandenburg
15827
Germany
Investigator Site Number: 2201
Münster
North Rhine-Westphalia
48149
Germany
Investigative Site Number: 2208
Kiel
Schleswig-Holstein
2405
Germany
Investigative Site Number: 2203
Berlin
10117
Germany
Investigative Site Number: 2204
Hamburg
20251
Germany
Investigative Site Number: 2305
Gyula
Bekes County
5700
Hungary
Investigative Site Number: 2307
Kecskemét
Bács-Kiskun county
6000
Hungary
Investigative Site Number: 2301
Szeged
Csongrád megye
6720
Hungary
Investigative Site Number: 2303
Debrecen
Hajdú-Bihar
4032
Hungary
Investigative Site Number: 2306
Szolnok
Jász-Nagykun-Szolnok
5000
Hungary
Investigative Site Number: 2302
Zalaegerszeg
Zala County
8900
Hungary
Investigative Site Number: 2304
Budapest
1036
Hungary
Investigative Site Number: 3103
Matsudo
Chiba
270-2223
Japan
Investigative Site Number: 3114
Obihiro-Shi
Hokkaidô
080-0013
Japan
Investigative site #3108
Kagoshima
Kagoshima-ken
890-0063
Japan
Investigative site #3113
Yokohama
Kanagawa
221-0825
Japan
Investigative Site Number: 3112
Adachi-Ku
Tokyo
120-0034
Japan
Investigative Site Number: 3115
Chuo Ku
Tokyo
Japan
Investigative Site Number: 3104
Edagowa-Ku
Tokyo
133-0052
Japan
Investigative Site Number: 3111
Koto-Ku
Tokyo
136-0074
Japan
Investigative Site Number: 3107
Minato-Ku
Tokyo
108-0014
Japan
Investigative site #3105
Setagaya-Ku
Tokyo
158-0097
Japan
Investigative site #3102
Kyoto
602-0841
Japan
Investigative Site Number: 3106
Mibu-machi
321-0293
Japan
Investigative site #3101
Sapporo
060-0063
Japan
Investigative Site Number: 3109
Habikino-Shi
Ôsaka
583-0872
Japan
Investigative Site Number: 3110
Sakaishi
Ôsaka
593-8324
Japan
Investigative Site Number: 2408
Krakow
Lesser Poland Voivodeship
30-033
Poland
Investigative Site Number: 2407
Krakow
Lesser Poland Voivodeship
30-510
Poland
Investigative Site Number: 2409
Krakow
Lesser Poland Voivodeship
31-011
Poland
Investigative Site Number: 2414
Wroclaw
Lower Silesian Voivodeship
50-088
Poland
Investigative Site Number: 2418
Wroclaw
Lower Silesian Voivodeship
50-368
Poland
Investigative Site Number: 2417
Wroclaw
Lower Silesian Voivodeship
51-685
Poland
Investigative Site Number: 2420
Lodz
Lódzkie
90-349
Poland
Investigative Site Number: 2415
Lódz
Lódzkie
90-127
Poland
Investigative Site Number: 2412
Warsaw
Masovian Voivodeship
00-874
Poland
Investigative Site Number: 2411
Warsaw
Masovian Voivodeship
01-142
Poland
Investigative Site Number: 2413
Warsaw
Masovian Voivodeship
01-192
Poland
Investigative Site Number: 2401
Rzeszów
Podkarpackie Voivodeship
35-055
Poland
Investigative site #2419
Bialystok
Podlaskie Voivodeship
15-879
Poland
Investigative Site Number: 2402
Gdansk
Pomeranian Voivodeship
80-382
Poland
Investigative Site Number: 2404
Gdynia
Pomeranian Voivodeship
81-384
Poland
Investigative Site Number: 2405
Katowice
Silesian Voivodeship
40-040
Poland
Investigative Site Number: 2410
Szczecin
West Pomeranian Voivodeship
71-434
Poland
Investigative site #2419
Bialystok
15-879
Poland
Investigative Site Number: 2403
Gdansk
80-592
Poland
Investigative Site Number: 2406
Krakow
31-559
Poland
Investigative site #2420
Lodz
90-349
Poland
Investigative Site Number: 2416
Lodz
Łódź Voivodeship
90-436
Poland
Investigative Site Number: 2502
Manises
Valencia
46940
Spain
Investigative Site Number: 2505
Alicante
3010
Spain
Investigative Site Number: 2501
Córdoba
14004
Spain
Investigative Site Number: 2503
Madrid
28046
Spain
Investigative Site Number: 2504
Pontevedra
36001
Spain
Investigative Site Number: 3201
Niao Song Qu
833
Taiwan
Investigative Site Number: 3202
Taichung
402
Taiwan
Investigative site # 3206
Taipei
11217
Taiwan
Investigative site # 3206
Taipei
112217
Taiwan
Investigative Site Number: 3203
Taoyuan
33305
Taiwan
Investigative Site Number: 2603
London
E11 1NR
United Kingdom
Investigative Site Number: 2601
London
SE1 9RT
United Kingdom
Investigative Site Number: 2602
Sheffield
S10 2TF
United Kingdom
Derived
Blauvelt A, Chovatiya R, Merola JF, Weidinger S, Igawa K, Brookes E, Weber C, Wang J, Gray C. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab. J Eur Acad Dermatol Venereol. 2025 Dec;39(12):2113-2120. doi: 10.1111/jdv.20877. Epub 2025 Jul 24.
Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, Lynde C, Kataoka Y, Foley P, Wei X, Wong W, Solente AC, Weber C, Adelman S, Davey S, Hurbin F, Rynkiewicz N, Yen K, O'Malley JT, Bernigaud C. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025 Apr;155(4):1264-1275. doi: 10.1016/j.jaci.2024.10.031. Epub 2024 Nov 8.
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
FG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
FG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
FG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
FG005
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
FG006
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
FG007
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
FG008
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
FG009
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
FG010
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
FG011
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
FG012
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
FG013
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
FG00077 subjects
FG00178 subjects
FG00277 subjects
FG00379 subjects
FG00479 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Randomized and Treated
FG00077 subjects
FG00178 subjects
FG00277 subjects
FG00378 subjects
FG00478 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Re-randomized at Week 24
FG00047 subjects
FG00140 subjects
FG00245 subjects
FG00342 subjects
FG00416 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG00068 subjects
FG00162 subjects
FG00269 subjects
FG00367 subjects
FG00457 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0009 subjects
FG00116 subjects
FG0028 subjects
FG00312 subjects
FG00422 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0019 subjects
FG0026 subjects
FG0032 subjects
FG0048 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0036 subjects
FG004
unclassified
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized and not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
PART 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00513 subjects
FG00634 subjects
FG00712 subjects
FG00828 subjects
FG00912 subjects
FG01033 subjects
FG0117 subjects
FG01235 subjects
FG01316 subjects
Re-randomized and Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
BG001
250 mg (No LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
BG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
BG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
BG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00077
BG00178
BG00277
BG00379
BG00479
BG005390
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.3± 13.32
BG00140.8± 15.24
BG00237.9± 15.17
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00135
BG002
Race (NIH/OMB)
There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
EASI Score at Baseline
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00030.3± 11.66
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation.
Posted
Least Squares Mean
Standard Error
percentage of change
Baseline to week 16
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG000-61.5± 4.68
OG001-56.8± 4.59
OG002-51.6± 4.59
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
ANCOVA
<0.0001
LS Mean Difference
-32.1
Standard Error of the Mean
6.01
2-Sided
95
-43.9
-20.3
LS Mean Difference
Superiority
OG001
OG004
ANCOVA
Secondary
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation.
Posted
Least Squares Mean
Standard Error
percentage of change
Baseline to week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to week 16 and week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Secondary
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to week 16 and week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to week 16 and week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders.
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
Secondary
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
score on a scale
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 2,4, 8,12,16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Secondary
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Secondary
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participant with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Posted
Number
Percentage of participants
Baseline to weeks 2, 4, 8,12,16,20 & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 4, 8, 12, 16, 20 & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of body surface area
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in Affected BSA From Baseline (Part 2)
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of body surface area
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Percentage Change in Affected BSA From Baseline (Part 1)
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage change
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
Secondary
Percentage Change in Affected BSA From Baseline (Part 2)
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage change
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 4, 8, 12, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 2, 8, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
Secondary
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 2, 8, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
Secondary
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized Participants at week 24. Only those participants with data available at specified time points are reported.
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 16, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
Secondary
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 24, 36 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 16, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
Secondary
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 24, 36 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to weeks 8 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
score on a scale
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 8, 16, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
Posted
Mean
Standard Deviation
Percentage of change
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Secondary
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Secondary
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
Secondary
Incidence Rate of Loss of EASI 50 (Part 2)
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Participants who reached EASI 50 at week 24 and re-randomized participants at week 24.
Posted
Number
Events per patient-year
Week 24 to week 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
Secondary
Incidence Rate of Loss of EASI 75 (Part 2)
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Participants who reached EASI 75 at week 24 and re-randomized participants at week 24.
Posted
Number
Events per patient-year
Week 24 to week 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
Secondary
Incidence Rate of Loss of IGA 0/1 (Part 2)
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Participants who had IGA response 0 or 1 at week 24 and re-randomized at week 24.
Posted
Number
Events per patient-year
Week 24 to week 68
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
Secondary
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
This analysis was conducted for Part 1 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported.
Posted
Mean
Standard Deviation
(ug/ml)
Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
Secondary
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
This analysis was conducted for Part 2 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported
Posted
Mean
Standard Deviation
(ug/ml)
Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Safety Analysis Part 1:Participants who took at least a dose of study treatment, including placebo up to Week 24. Analysis based on the SAF1 was based on the treatment received, regardless of assigned treatment according to the randomization
Posted
Number
Percentage of participants
Baseline through week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Secondary
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least a dose of study treatment on/or after Week 24. Any analysis based on the SAF2 was based on the treatment at Week 24, regardless of treatment according to the randomization.
Posted
Number
Percentage of participants
Week 24 through week 68
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Secondary
Percentage of Participants With Treatment-emergent ADA (Part 1)
The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.
Posted
Number
Percentage of participants
Baseline through week 24
ID
Title
Description
OG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
OG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
OG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
Secondary
Percentage of Participants With Treatment-emergent ADA (Part 2)
The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24.
Posted
Number
Percentage of participants
Baseline through week 68
ID
Title
Description
OG000
250 mg KY1005 Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG001
Placebo Re-randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
Time Frame
Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Description
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization.
Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
0
77
2
77
42
77
EG001
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
0
78
0
78
39
78
EG002
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
0
77
1
77
39
77
EG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
0
78
5
78
41
78
EG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
0
78
1
78
41
78
EG005
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
0
13
1
13
11
13
EG006
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
0
34
1
34
21
34
EG007
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
0
11
0
11
7
11
EG008
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
0
28
2
28
19
28
EG009
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
0
12
1
12
8
12
EG010
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
0
32
0
32
27
32
EG011
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
0
7
0
7
4
7
EG012
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
0
34
0
34
21
34
EG013
Placebo (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
0
15
0
15
10
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected78 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected28 at risk
EG0090 events0 affected12 at risk
EG0100 events0 affected32 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected34 at risk
EG0130 events0 affected15 at risk
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Tension Headache
Nervous system disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected78 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected13 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected28 at risk
EG0090 events0 affected12 at risk
EG0100 events0 affected32 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected34 at risk
EG0130 events0 affected15 at risk
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0012 events2 affected78 at risk
EG0021 events1 affected77 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
FATIGUE
General disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected77 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
BRONCHITIS VIRAL
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
COVID-19
Infections and infestations
Systematic Assessment
EG0006 events6 affected77 at risk
EG0017 events7 affected78 at risk
EG0027 events7 affected77 at risk
EG003
CYSTITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected77 at risk
EG003
DERMATITIS INFECTED
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
FOLLICULITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0023 events1 affected77 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
HERPES SIMPLEX
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
INFLUENZA
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected77 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
Systematic Assessment
EG00019 events14 affected77 at risk
EG0018 events6 affected78 at risk
EG00212 events9 affected77 at risk
EG003
ORAL HERPES
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected77 at risk
EG003
OTITIS Media
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
PHARYNGITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
PYURIA
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
RHINITIS
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
SINUSITIS
Infections and infestations
Systematic Assessment
EG0002 events1 affected77 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected77 at risk
EG003
TONSILLITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0013 events2 affected78 at risk
EG0024 events4 affected77 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0013 events1 affected78 at risk
EG0020 events0 affected77 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Systematic Assessment
EG0002 events2 affected77 at risk
EG0013 events3 affected78 at risk
EG0023 events2 affected77 at risk
EG003
ACCIDENTAL OVERDOSE
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected77 at risk
EG0013 events3 affected78 at risk
EG0021 events1 affected77 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
Systematic Assessment
EG0003 events2 affected77 at risk
EG0012 events2 affected78 at risk
EG0021 events1 affected77 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
Systematic Assessment
EG0000 events0 affected77 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected77 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
Systematic Assessment
EG0005 events4 affected77 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected77 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected77 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
PERIOSTITIS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
DIZZINESS
Nervous system disorders
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected78 at risk
EG0023 events2 affected77 at risk
EG003
HEADACHE
Nervous system disorders
Systematic Assessment
EG0004 events4 affected77 at risk
EG0014 events4 affected78 at risk
EG0024 events4 affected77 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
TENSION HEADACHE
Nervous system disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
HEAVY MENSTRUAL BLEEDING
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 events2 affected77 at risk
EG0010 events0 affected78 at risk
EG0022 events2 affected77 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00010 events9 affected77 at risk
EG00122 events16 affected78 at risk
EG00219 events15 affected77 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
ROSACEA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected77 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected77 at risk
EG003
HYPERTENSION
Vascular disorders
Systematic Assessment
EG0002 events2 affected77 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected77 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
4 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
4 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
5 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG00513 subjects
FG00634 subjects
FG00711 subjects
FG00828 subjects
FG00912 subjects
FG01032 subjects
FG0117 subjects
FG01234 subjects
FG01315 subjects
0 subjects
FG00512 subjects
FG00631 subjects
FG00711 subjects
FG00824 subjects
FG00911 subjects
FG01028 subjects
FG0117 subjects
FG01229 subjects
FG01313 subjects
0 subjects
FG0051 subjects
FG0063 subjects
FG0071 subjects
FG0084 subjects
FG0091 subjects
FG0105 subjects
FG0110 subjects
FG0126 subjects
FG0133 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0122 subjects
FG0132 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0083 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0122 subjects
FG0130 subjects
Unclassified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Re-randomized and not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0131 subjects
37.6
± 14.78
BG00436.4± 13.07
BG00537.8± 14.36
39
BG00337
BG00430
BG005171
Male
BG00047
BG00143
BG00238
BG00342
BG00449
BG005219
0
BG0030
BG0040
BG0050
Asian
BG00012
BG00112
BG00210
BG00314
BG00412
BG00560
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0004
BG0012
BG0024
BG0034
BG0046
BG00520
White
BG00061
BG00163
BG00263
BG00360
BG00460
BG005307
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0031
BG0041
BG0053
28.7
± 10.53
BG00230.3± 12.43
BG00328.7± 10.09
BG00426.4± 7.85
BG00528.9± 10.65
79
OG00479
-59.6
± 4.53
OG004-29.4± 4.76
<0.0001
LS Mean Difference
-27.3
Standard Error of the Mean
5.98
2-Sided
95
-39.1
-15.6
LS Mean Difference
Superiority
OG002
OG004
ANCOVA
0.0002
LS Mean Difference
-22.2
Standard Error of the Mean
6.01
2-Sided
95
-34.0
-10.4
LS Mean Difference
Superiority
OG003
OG004
ANCOVA
<0.0001
Mean Difference (Final Values)
-30.2
Standard Error of the Mean
5.95
2-Sided
95
-41.9
-18.5
Superiority
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Title
Measurements
OG000-64.4± 5.17
OG001-52.2± 5.14
OG002-53.7± 5.08
OG003-54.4± 5.09
OG004-27.6± 5.29
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
ANCOVA
<0.0001
LS Mean Difference
-36.8
Standard Error of the Mean
6.62
2-Sided
95
-49.8
-23.8
LS Mean Difference
Superiority
OG001
OG004
ANCOVA
0.0002
LS Mean Difference
-24.6
Standard Error of the Mean
6.67
2-Sided
95
-37.7
-11.6
LS Mean Difference
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-26.2
Standard Error of the Mean
6.65
2-Sided
95
-39.2
-13.1
LS Mean Difference
Superiority
OG003
OG004
ANCOVA
<0.0001
LS Mean Difference
-26.8
Standard Error of the Mean
6.58
2-Sided
95
-39.7
-13.9
LS Mean Difference
Superiority
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 16
Title
Measurements
OG00040.3
OG00138.5
OG00242.9
OG00340.5
OG00411.4
Week 24
Title
Measurements
OG00054.5
OG00138.5
OG00249.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Week 16
Cochran-Mantel-Haenszel
< 0.0001
Proportion Difference
0.29
2-Sided
95
0.16
0.42
Superiority
OG001
OG004
Week 16
Cochran-Mantel-Haenszel
< 0.0001
Proportion Difference
0.27
2-Sided
95
0.14
0.40
Superiority
OG002
OG004
Week 16
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.31
2-Sided
95
0.18
0.44
Superiority
OG003
OG004
Week 16
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.29
2-Sided
95
0.16
0.42
Superiority
OG000
OG004
Week 24
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.36
2-Sided
95
0.23
0.5
Superiority
OG001
OG004
Week 24
Cochran-Mantel-Haenszel
0.0040
Proportion Difference
0.21
2-Sided
95
0.07
0.34
Superiority
OG002
OG004
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.31
2-Sided
95
0.17
0.45
Superiority
OG003
OG004
Cochran-Mantel-Haenszel
0.0016
Proportion Difference
0.23
2-Sided
95
0.09
0.36
Superiority
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 16
Title
Measurements
OG00022.1
OG00114.1
OG00219.5
OG00325.3
OG0045.1
Week 24
Title
Measurements
OG00045.5
OG00133.3
OG00240.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Week 16
Cochran-Mantel-Haenszel
0.0022
Proportion Difference
0.17
2-Sided
95
0.06
0.27
Superiority
OG001
OG004
Week 16
Cochran-Mantel-Haenszel
0.0562
Proportion Difference
0.09
2-Sided
95
0
0.18
Superiority
OG002
OG004
Week 16
Cochran-Mantel-Haenszel
0.0054
Proportion Difference
0.14
2-Sided
95
0.04
0.24
Superiority
OG003
OG004
Week 16
Cochran-Mantel-Haenszel
0.0003
Proportion Difference
0.2
2-Sided
95
0.1
0.31
Superiority
OG000
OG004
Week 24
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.34
2-Sided
95
0.21
0.47
Superiority
OG001
OG004
Week 24
Cochran-Mantel-Haenszel
0.0008
Proportion Difference
0.22
2-Sided
95
0.1
0.34
Superiority
OG002
OG004
Week 24
Cochran-Mantel-Haenszel
<0.0001
Proportion Difference
0.29
2-Sided
95
0.16
0.41
Superiority
OG003
OG004
Week 24
Cochran-Mantel-Haenszel
0.0046
Proportion Difference
0.18
2-Sided
95
0.06
0.3
Superiority
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 16
Title
Measurements
OG00024.7
OG00119.2
OG00220.8
OG00322.8
OG0045.1
Week 24
Title
Measurements
OG00031.2
OG00124.4
OG00228.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Week 16
Cochran-Mantel-Haenszel
0.0006
Proportion Difference
0.19
2-Sided
95
0.09
0.3
Superiority
OG001
OG004
Week 16
Cochran-Mantel-Haenszel
0.0057
Proportion Difference
0.14
2-Sided
95
0.04
0.24
Superiority
OG002
OG004
Week 16
Cochran-Mantel-Haenszel
0.0038
Proportion Difference
0.16
2-Sided
95
0.05
0.26
Superiority
OG003
OG004
Week 16
Cochran-Mantel-Haenszel
0.0011
Proportion Difference
0.18
2-Sided
95
0.07
0.28
Superiority
OG000
OG004
Week 24
Cochran-Mantel-Haenszel
0.0002
Proportion Difference
0.23
2-Sided
95
0.11
0.35
Superiority
OG001
OG004
Week 24
Cochran-Mantel-Haenszel
0.0038
Proportion Difference
0.17
2-Sided
95
0.06
0.28
Superiority
OG002
OG004
Week 24
Cochran-Mantel-Haenszel
0.0006
Proportion Difference
0.21
2-Sided
95
0.09
0.32
Superiority
OG003
OG004
Week 24
Cochran-Mantel-Haenszel
0.0008
Proportion Difference
20
2-Sided
95
9
32
Superiority
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
Title
Measurements
OG00053.8
OG00141.2
OG00275.0
OG00335.7
OG00458.3
OG00545.5
OG00671.4
OG00745.7
OG00825.0
Week 25
Title
Measurements
OG00053.8
OG00141.2
OG00266.7
OG003
Week 26
Title
Measurements
OG00053.8
OG00138.2
OG00266.7
OG003
Week 27
Title
Measurements
OG00061.5
OG00135.3
OG00258.3
OG003
Week 28
Title
Measurements
OG00061.5
OG00135.3
OG00266.7
OG003
Week 29
Title
Measurements
OG00069.2
OG00138.2
OG00250.0
OG003
Week 30
Title
Measurements
OG00061.5
OG00144.1
OG00258.3
OG003
Week 31
Title
Measurements
OG00061.5
OG00141.2
OG00258.3
OG003
Week 32
Title
Measurements
OG00061.5
OG00147.1
OG00250.0
OG003
Week 33
Title
Measurements
OG00061.5
OG00147.1
OG00258.3
OG003
Week 34
Title
Measurements
OG00061.5
OG00141.2
OG00275.0
OG003
Week 35
Title
Measurements
OG00061.5
OG00141.2
OG00266.7
OG003
Week 36
Title
Measurements
OG00061.5
OG00138.2
OG00258.3
OG003
Week 37
Title
Measurements
OG00053.8
OG00141.2
OG00250.0
OG003
Week 38
Title
Measurements
OG00053.8
OG00135.3
OG00250.0
OG003
Week 39
Title
Measurements
OG00053.8
OG00141.2
OG00250.0
OG003
Week 40
Title
Measurements
OG00053.8
OG00138.2
OG00233.3
OG003
Week 41
Title
Measurements
OG00061.5
OG00135.3
OG00241.7
OG003
Week 42
Title
Measurements
OG00053.8
OG00138.2
OG00250.0
OG003
Week 43
Title
Measurements
OG00053.8
OG00135.3
OG00250.0
OG003
Week 44
Title
Measurements
OG00061.5
OG00138.2
OG00241.7
OG003
Week 45
Title
Measurements
OG00061.5
OG00141.2
OG00241.7
OG003
Week 46
Title
Measurements
OG00053.8
OG00144.1
OG00250.0
OG003
Week 47
Title
Measurements
OG00046.2
OG00138.2
OG00233.3
OG003
Week 48
Title
Measurements
OG00038.5
OG00135.3
OG00241.7
OG003
Week 49
Title
Measurements
OG00038.5
OG00141.2
OG00250.0
OG003
Week 50
Title
Measurements
OG00038.5
OG00135.3
OG00250.0
OG003
Week 51
Title
Measurements
OG00030.8
OG00132.4
OG00241.7
OG003
Week 52
Title
Measurements
OG00046.2
OG00129.4
OG00241.7
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00073
ParticipantsOG00177
ParticipantsOG00275
ParticipantsOG00375
ParticipantsOG00478
Title
Measurements
OG000-8.49± 10.777
OG001-5.27± 8.485
OG002-6.17± 10.071
OG003
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00073
ParticipantsOG00177
ParticipantsOG00275
ParticipantsOG00375
ParticipantsOG00478
Title
Measurements
OG000-27.94± 30.032
OG001-17.75± 38.988
OG002-19.09± 39.499
OG003
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00533
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-29.65± 11.278
OG001-26.28± 13.353
OG002-27.60± 11.170
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00533
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-91.71± 8.539
OG001-81.85± 31.624
OG002-84.20± 16.741
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
Title
Measurements
OG00019.5
OG00115.4
OG00216.9
OG00322.8
OG00413.9
Week 4
Title
Measurements
OG00029.9
OG00121.8
OG00239.0
OG003
Week 8
Title
Measurements
OG00045.5
OG00138.5
OG00253.2
OG003
Week 12
Title
Measurements
OG00062.3
OG00144.9
OG00261.0
OG003
Week 16
Title
Measurements
OG00063.6
OG00152.6
OG00257.1
OG003
Week 20
Title
Measurements
OG00063.6
OG00151.3
OG00258.4
OG003
Week 24
Title
Measurements
OG00066.2
OG00143.6
OG00255.8
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
Title
Measurements
OG0009.1
OG0012.6
OG0022.6
OG0032.5
OG0045.1
Week 4
Title
Measurements
OG0009.1
OG0019.0
OG00211.7
OG003
Week 8
Title
Measurements
OG00023.4
OG00116.7
OG00227.3
OG003
Week 12
Title
Measurements
OG00033.8
OG00125.6
OG00244.2
OG003
Week 16
Title
Measurements
OG00040.3
OG00138.5
OG00242.9
OG003
Week 20
Title
Measurements
OG00049.4
OG00142.3
OG00248.1
OG003
Week 24
Title
Measurements
OG00054.5
OG00138.5
OG00249.4
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
Title
Measurements
OG0002.6
OG0011.3
OG0020
OG0031.3
OG0040
Week 4
Title
Measurements
OG0006.5
OG0011.3
OG0021.3
OG003
Week 8
Title
Measurements
OG0007.8
OG0017.7
OG0029.1
OG003
Week 12
Title
Measurements
OG00010.4
OG0019.0
OG00214.3
OG003
Week 16
Title
Measurements
OG00015.6
OG00114.1
OG00216.9
OG003
Week 20
Title
Measurements
OG00027.3
OG00123.1
OG00224.7
OG003
Week 24
Title
Measurements
OG00037.7
OG00126.9
OG00232.5
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000
OG0011.3
OG0020
OG0030
OG0040
Week 4
Title
Measurements
OG0002.6
OG0010
OG0020
OG003
Week 8
Title
Measurements
OG0002.6
OG0015.1
OG0021.3
OG003
Week 12
Title
Measurements
OG0003.9
OG0012.6
OG0022.6
OG003
Week 16
Title
Measurements
OG0003.9
OG0011.3
OG0022.6
OG003
Week 20
Title
Measurements
OG0006.5
OG0016.4
OG0023.9
OG003
Week 24
Title
Measurements
OG0007.8
OG0016.4
OG0029.1
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00073
ParticipantsOG00177
ParticipantsOG00275
ParticipantsOG00375
ParticipantsOG00478
Title
Measurements
OG000-0.33± 0.625
OG001-0.21± 0.408
OG002-0.29± 0.540
OG003
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00533
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-2.31± 0.855
OG001-1.91± 1.026
OG002-2.00± 0.953
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
Title
Measurements
OG0001.3
OG0010
OG0020
OG0030
OG0041.3
Week 4
Title
Measurements
OG0005.2
OG0011.3
OG0021.3
OG003
Week 8
Title
Measurements
OG0009.1
OG0019.0
OG00213.0
OG003
Week 12
Title
Measurements
OG00016.9
OG00112.8
OG00219.5
OG003
Week 16
Title
Measurements
OG00022.1
OG00114.1
OG00219.5
OG003
Week 20
Title
Measurements
OG00033.8
OG00125.6
OG00227.3
OG003
Week 24
Title
Measurements
OG00045.5
OG00133.3
OG00240.3
OG003
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
ParticipantsOG00475
Title
Measurements
OG000-15.30± 16.517
OG001-12.27± 13.455
OG002-15.89± 14.865
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-52.22± 14.314
OG001-44.25± 21.373
OG002-42.44± 21.879
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
ParticipantsOG00475
Title
Measurements
OG000-22.02± 22.050
OG001-18.52± 20.315
OG002-22.76± 20.903
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-76.47± 11.581
OG001-63.86± 27.005
OG002-60.09± 26.373
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00032
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00339
ParticipantsOG00438
Title
Measurements
OG000-4.50± 10.610
OG001-5.61± 10.165
OG002-9.08± 15.999
OG003
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-46.92± 22.009
OG001-37.94± 18.723
OG002-37.17± 17.994
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00032
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00339
ParticipantsOG00438
Title
Measurements
OG000-10.11± 24.013
OG001-12.23± 26.053
OG002-19.43± 30.139
OG003
Week 4
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00275
ParticipantsOG00376
Week 12
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-88.09± 12.983
OG001-78.75± 27.966
OG002-80.67± 27.843
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 4
ParticipantsOG00075
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00377
ParticipantsOG00475
Title
Measurements
OG000-4.40± 6.403
OG001-4.01± 6.287
OG002-5.42± 6.498
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00376
Week 12
ParticipantsOG00069
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00069
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00066
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-15.31± 6.061
OG001-11.97± 6.410
OG002-11.58± 8.586
OG003
Week 32
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 4
ParticipantsOG00075
ParticipantsOG00173
ParticipantsOG00276
ParticipantsOG00377
ParticipantsOG00475
Title
Measurements
OG000-20.81± 34.179
OG001-21.02± 31.360
OG002-22.77± 30.783
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00376
Week 12
ParticipantsOG00069
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00377
Week 16
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00066
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-72.61± 19.898
OG001-61.00± 30.657
OG002-54.05± 38.147
OG003
Week 32
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00071
ParticipantsOG00177
ParticipantsOG00275
ParticipantsOG00375
ParticipantsOG00478
Title
Measurements
OG000-3.63± 4.992
OG001-2.82± 4.850
OG002-3.32± 5.745
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00376
Week 16
ParticipantsOG00067
ParticipantsOG00167
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00066
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-12.54± 6.703
OG001-9.00± 6.290
OG002-9.08± 6.487
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 2
ParticipantsOG00071
ParticipantsOG00177
ParticipantsOG00275
ParticipantsOG00374
ParticipantsOG00478
Title
Measurements
OG000-22.68± 31.305
OG001-11.95± 47.921
OG002-16.80± 41.680
OG003
Week 8
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00375
Week 16
ParticipantsOG00067
ParticipantsOG00167
ParticipantsOG00273
ParticipantsOG00375
Week 20
ParticipantsOG00066
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00370
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-75.53± 26.705
OG001-61.64± 35.809
OG002-64.74± 31.091
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00328
Week 32
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00328
Week 36
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00328
Week 40
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
Week 44
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00328
Week 48
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00328
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00328
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 16
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00273
ParticipantsOG00376
ParticipantsOG00468
Title
Measurements
OG000-6.70± 5.813
OG001-5.41± 6.054
OG002-6.22± 6.272
OG003
Week 24
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00368
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00128
ParticipantsOG00212
ParticipantsOG00327
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00731
ParticipantsOG00816
Title
Measurements
OG000-11.23± 6.071
OG001-8.64± 5.927
OG002-9.83± 6.506
OG003
Week 36
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00210
ParticipantsOG00327
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00327
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 16
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00273
ParticipantsOG00376
ParticipantsOG00468
Title
Measurements
OG000-40.56± 37.340
OG001-33.42± 34.745
OG002-36.42± 37.103
OG003
Week 24
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00368
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00128
ParticipantsOG00212
ParticipantsOG00327
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00731
ParticipantsOG00816
Title
Measurements
OG000-66.75± 32.632
OG001-57.08± 37.656
OG002-56.01± 36.112
OG003
Week 36
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00210
ParticipantsOG00327
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00327
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 8
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00274
ParticipantsOG00376
ParticipantsOG00472
Title
Measurements
OG000-2.20± 4.639
OG001-2.07± 6.194
OG002-2.35± 5.641
OG003
Week 16
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00273
ParticipantsOG00376
Week 20
ParticipantsOG00066
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00372
Week 24
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00327
ParticipantsOG00412
ParticipantsOG00531
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-4.54± 8.482
OG001-1.73± 7.434
OG002-5.58± 10.184
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00327
Week 32
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00327
Week 36
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00327
Week 40
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00327
Week 44
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00211
ParticipantsOG00327
Week 48
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00327
Week 52
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00211
ParticipantsOG00327
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 8
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00376
ParticipantsOG00469
Title
Measurements
OG000-18.40± 46.151
OG001-11.76± 48.829
OG002-10.22± 56.395
OG003
Week 16
ParticipantsOG00066
ParticipantsOG00165
ParticipantsOG00269
ParticipantsOG00376
Week 20
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00268
ParticipantsOG00372
Week 24
ParticipantsOG00069
ParticipantsOG00165
ParticipantsOG00266
ParticipantsOG00370
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
ParticipantsOG00411
ParticipantsOG00529
ParticipantsOG0065
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-28.01± 54.369
OG001-17.89± 76.693
OG002-34.27± 48.841
OG003
Week 28
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
Week 32
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00326
Week 36
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG0029
ParticipantsOG00326
Week 40
ParticipantsOG00013
ParticipantsOG00129
ParticipantsOG00210
ParticipantsOG00326
Week 44
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG00210
ParticipantsOG00326
Week 48
ParticipantsOG00013
ParticipantsOG00130
ParticipantsOG0029
ParticipantsOG00326
Week 52
ParticipantsOG00013
ParticipantsOG00129
ParticipantsOG00210
ParticipantsOG00326
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 1
ParticipantsOG00074
ParticipantsOG00177
ParticipantsOG00277
ParticipantsOG00377
ParticipantsOG00477
Title
Measurements
OG000-0.54± 1.096
OG001-0.56± 0.978
OG002-0.49± 0.965
OG003
Week 2
ParticipantsOG00075
ParticipantsOG00177
ParticipantsOG00276
ParticipantsOG00376
Week 3
ParticipantsOG00075
ParticipantsOG00177
ParticipantsOG00277
ParticipantsOG00377
Week 4
ParticipantsOG00075
ParticipantsOG00176
ParticipantsOG00276
ParticipantsOG00377
Week 5
ParticipantsOG00075
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00377
Week 6
ParticipantsOG00074
ParticipantsOG00173
ParticipantsOG00275
ParticipantsOG00376
Week 7
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG00376
Week 8
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00273
ParticipantsOG00375
Week 9
ParticipantsOG00074
ParticipantsOG00173
ParticipantsOG00274
ParticipantsOG00375
Week 10
ParticipantsOG00072
ParticipantsOG00173
ParticipantsOG00272
ParticipantsOG00374
Week 11
ParticipantsOG00073
ParticipantsOG00170
ParticipantsOG00273
ParticipantsOG00374
Week 12
ParticipantsOG00072
ParticipantsOG00169
ParticipantsOG00271
ParticipantsOG00373
Week 13
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00373
Week 14
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00375
Week 15
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00271
ParticipantsOG00374
Week 16
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00375
Week 17
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00375
Week 18
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00268
ParticipantsOG00375
Week 19
ParticipantsOG00069
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00375
Week 20
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00269
ParticipantsOG00372
Week 21
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00372
Week 22
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00372
Week 23
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00371
Week 24
ParticipantsOG00070
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00371
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00326
ParticipantsOG00411
ParticipantsOG00533
ParticipantsOG0066
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-3.63± 2.380
OG001-2.83± 2.909
OG002-4.00± 2.711
OG003
Week 25
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00325
Week 26
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00325
Week 27
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00324
Week 28
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00326
Week 29
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00325
Week 30
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 31
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00325
Week 33
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00326
Week 34
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00326
Week 35
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 36
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 37
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 38
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00326
Week 39
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
Week 40
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00326
Week 41
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00326
Week 42
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 43
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 45
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00327
Week 46
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00327
Week 47
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00327
Week 48
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00327
Week 49
ParticipantsOG00012
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00327
Week 50
ParticipantsOG00012
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00327
Week 51
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG00210
ParticipantsOG00327
Week 52
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG0029
ParticipantsOG00327
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 1
ParticipantsOG00074
ParticipantsOG00177
ParticipantsOG00277
ParticipantsOG00377
ParticipantsOG00477
Title
Measurements
OG000-6.26± 16.312
OG001-7.25± 13.575
OG002-6.18± 13.809
OG003
Week 2
ParticipantsOG00075
ParticipantsOG00177
ParticipantsOG00276
ParticipantsOG00376
Week 3
ParticipantsOG00075
ParticipantsOG00177
ParticipantsOG00277
ParticipantsOG00377
Week 4
ParticipantsOG00075
ParticipantsOG00176
ParticipantsOG00276
ParticipantsOG00377
Week 5
ParticipantsOG00075
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00377
Week 6
ParticipantsOG00074
ParticipantsOG00173
ParticipantsOG00275
ParticipantsOG00376
Week 7
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG00376
Week 8
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00273
ParticipantsOG00375
Week 9
ParticipantsOG00074
ParticipantsOG00173
ParticipantsOG00274
ParticipantsOG00375
Week 10
ParticipantsOG00072
ParticipantsOG00173
ParticipantsOG00272
ParticipantsOG00374
Week 11
ParticipantsOG00073
ParticipantsOG00170
ParticipantsOG00273
ParticipantsOG00374
Week 12
ParticipantsOG00072
ParticipantsOG00169
ParticipantsOG00271
ParticipantsOG00373
Week 13
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00373
Week 14
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00375
Week 15
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00271
ParticipantsOG00374
Week 16
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00375
Week 17
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00375
Week 18
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00268
ParticipantsOG00375
Week 19
ParticipantsOG00069
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00375
Week 20
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00269
ParticipantsOG00372
Week 21
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00372
Week 22
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00372
Week 23
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00371
Week 24
ParticipantsOG00070
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00371
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Week 24
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00326
ParticipantsOG00411
ParticipantsOG00533
ParticipantsOG0066
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG000-49.61± 33.036
OG001-38.71± 44.259
OG002-52.36± 33.258
OG003
Week 25
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00325
Week 26
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00325
Week 27
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00324
Week 28
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00326
Week 29
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00325
Week 30
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 31
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
Week 32
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00325
Week 33
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00326
Week 34
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00326
Week 35
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 36
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 37
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00327
Week 38
ParticipantsOG00013
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00326
Week 39
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00326
Week 40
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00326
Week 41
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00326
Week 42
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 43
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 44
ParticipantsOG00013
ParticipantsOG00132
ParticipantsOG00211
ParticipantsOG00327
Week 45
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00327
Week 46
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG00210
ParticipantsOG00327
Week 47
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00327
Week 48
ParticipantsOG00012
ParticipantsOG00132
ParticipantsOG0029
ParticipantsOG00327
Week 49
ParticipantsOG00012
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00327
Week 50
ParticipantsOG00012
ParticipantsOG00131
ParticipantsOG00210
ParticipantsOG00327
Week 51
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG00210
ParticipantsOG00327
Week 52
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG0029
ParticipantsOG00327
OG003
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00379
OG00479
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.6
OG0011.3
OG0021.3
OG0031.3
OG0041.3
Week 2
Title
Measurements
OG0003.9
OG0016.4
OG0021.3
OG003
Week 3
Title
Measurements
OG0009.1
OG0016.4
OG00210.4
OG003
Week 4
Title
Measurements
OG00010.4
OG00114.1
OG00215.6
OG003
Week 5
Title
Measurements
OG00015.6
OG00115.4
OG00216.9
OG003
Week 6
Title
Measurements
OG00010.4
OG00119.2
OG00218.2
OG003
Week 7
Title
Measurements
OG00016.9
OG00123.1
OG00220.8
OG003
Week 8
Title
Measurements
OG00022.1
OG00117.9
OG00222.1
OG003
Week 9
Title
Measurements
OG00020.8
OG00119.2
OG00227.3
OG003
Week 10
Title
Measurements
OG00027.3
OG00123.1
OG00228.6
OG003
Week 11
Title
Measurements
OG00026.0
OG00123.1
OG00231.2
OG003
Week 12
Title
Measurements
OG00026.0
OG00120.5
OG00228.6
OG003
Week 13
Title
Measurements
OG00028.6
OG00126.9
OG00229.9
OG003
Week 14
Title
Measurements
OG00035.1
OG00129.5
OG00228.6
OG003
Week 15
Title
Measurements
OG00029.9
OG00128.2
OG00228.6
OG003
Week 16
Title
Measurements
OG00032.5
OG00133.3
OG00229.9
OG003
Week 17
Title
Measurements
OG00032.5
OG00130.8
OG00227.3
OG003
Week 18
Title
Measurements
OG00036.4
OG00133.3
OG00229.9
OG003
Week 19
Title
Measurements
OG00035.1
OG00132.1
OG00233.8
OG003
Week 20
Title
Measurements
OG00033.8
OG00130.8
OG00231.2
OG003
Week 21
Title
Measurements
OG00037.7
OG00132.1
OG00233.8
OG003
Week 22
Title
Measurements
OG00037.7
OG00130.8
OG00233.8
OG003
Week 23
Title
Measurements
OG00041.6
OG00135.9
OG00237.7
OG003
Week 24
Title
Measurements
OG00040.3
OG00130.8
OG00236.4
OG003
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010.272
OG0020.188
OG0030.089
OG0040.165
OG0050.071
OG0060
OG0070.193
OG0080.145
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00012
OG00134
OG00212
OG00327
OG00411
OG00533
OG0067
OG00734
OG00816
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010.587
OG0020.375
OG0030.486
OG0040.395
OG0050.446
OG0060.351
OG0070.573
OG0080.646
OG002
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00212
OG00328
OG00412
OG00533
OG0067
OG00735
OG00816
Title
Denominators
Categories
Title
Measurements
OG0001.267
OG0011.039
OG0020.981
OG0031.930
OG0041.154
OG0051.045
OG0061.096
OG0071.790
OG0080.244
Units
Counts
Participants
OG00077
OG00176
OG00277
OG00377
Title
Denominators
Categories
Baseline
ParticipantsOG00077
ParticipantsOG00174
ParticipantsOG00276
ParticipantsOG00373
Title
Measurements
OG0000.00± 0.014
OG0010.00± 0.014
OG0020.01± 0.074
OG003
Week 1
ParticipantsOG00072
ParticipantsOG00173
ParticipantsOG00274
ParticipantsOG00373
Week 2
ParticipantsOG00065
ParticipantsOG00169
ParticipantsOG00267
ParticipantsOG00370
Week 4
ParticipantsOG00062
ParticipantsOG00165
ParticipantsOG00269
ParticipantsOG00368
Week 8
ParticipantsOG00053
ParticipantsOG00148
ParticipantsOG00256
ParticipantsOG00361
Week 12
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00254
ParticipantsOG00360
Week 16
ParticipantsOG00049
ParticipantsOG00148
ParticipantsOG00249
ParticipantsOG00352
Week 17
ParticipantsOG00049
ParticipantsOG00154
ParticipantsOG00254
ParticipantsOG00351
Week 20
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00254
ParticipantsOG00356
Week 24
ParticipantsOG00041
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG00343
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00211
OG00328
OG00412
OG00531
OG0067
OG00734
Title
Denominators
Categories
Week 24
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00211
ParticipantsOG00319
ParticipantsOG00410
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG00719
Title
Measurements
OG00045.13± 15.842
OG00136.68± 17.544
OG00245.00± 14.568
OG003
Week 25
ParticipantsOG00012
ParticipantsOG00128
ParticipantsOG00210
ParticipantsOG00323
Week 28
ParticipantsOG00013
ParticipantsOG00123
ParticipantsOG00211
ParticipantsOG00321
Week 32
ParticipantsOG00011
ParticipantsOG00120
ParticipantsOG00210
ParticipantsOG00315
Week 36
ParticipantsOG0009
ParticipantsOG00120
ParticipantsOG0029
ParticipantsOG00316
Week 40
ParticipantsOG0009
ParticipantsOG00120
ParticipantsOG0029
ParticipantsOG00318
Week 44
ParticipantsOG00010
ParticipantsOG00121
ParticipantsOG0028
ParticipantsOG00318
Week 48
ParticipantsOG00011
ParticipantsOG00118
ParticipantsOG0028
ParticipantsOG00319
Week 52
ParticipantsOG00010
ParticipantsOG00120
ParticipantsOG00210
ParticipantsOG00317
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
OG004
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
Units
Counts
Participants
OG00077
OG00178
OG00277
OG00378
OG00478
Title
Denominators
Categories
Any Treatment Emergent Adverse Event
Title
Measurements
OG00066.2
OG00166.7
OG00267.5
OG00367.9
OG00460.3
Any Serious Treatment Emergent Adverse Event
Title
Measurements
OG0002.6
OG0010
OG0021.3
OG003
OG003
Placebo Re-randomized From the 250mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG008
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
Units
Counts
Participants
OG00013
OG00134
OG00211
OG00328
OG00412
OG00532
OG0067
OG00734
OG00815
Title
Denominators
Categories
Any Treatment Emergent Adverse Event
Title
Measurements
OG00084.6
OG00167.6
OG00263.6
OG00378.6
OG00466.7
OG00587.5
OG00657.1
OG00767.6
OG00866.7
Any Serious Treatment Emergent Adverse Event
Title
Measurements
OG0007.7
OG0012.9
OG0020
OG003
Units
Counts
Participants
OG00077
OG00176
OG00277
OG00377
Title
Denominators
Categories
Title
Measurements
OG0002.6
OG0016.4
OG00213.2
OG00332.1
OG003
Placebo Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG004
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
OG005
Placebo Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
OG006
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
OG007
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52