Phase 2b Study to Evaluate the Efficacy and Safety of ISB... | NCT03568162 | Trialant
NCT03568162
Sponsor
Ichnos Sciences SA
Status
Completed
Last Update Posted
Aug 23, 2022Actual
Enrollment
462Actual
Phase
Phase 2
Conditions
Moderate to Severe Atopic Dermatitis
Interventions
ISB 830 - Part 1 Group 1
ISB 830 - Part 1 Group 2
ISB 830 - Part 1 Group 3
Placebo - Part 1 Group 4
ISB 830 - Part 2 Group 5
Placebo - Part 2 Group 6
Countries
United States
Canada
Czechia
Germany
Poland
Protocol Section
Identification Module
NCT ID
NCT03568162
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GBR 830-204
Secondary IDs
ID
Type
Description
Link
2018-000783-29
EudraCT Number
Brief Title
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
Acronym
Not provided
Organization
Ichnos Sciences SAINDUSTRY
Status Module
Record Verification Date
Jul 2022
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
May 31, 2018Actual
Primary Completion Date
Aug 11, 2020Actual
Completion Date
Aug 3, 2021Actual
First Submitted Date
May 31, 2018
First Submission Date that Met QC Criteria
Jun 22, 2018
First Posted Date
Jun 26, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 2, 2022
Results First Submitted that Met QC Criteria
Jun 2, 2022
Results First Posted Date
Jun 28, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 26, 2022
Last Update Posted Date
Aug 23, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ichnos Sciences SAINDUSTRY
Collaborators
Name
Class
Glenmark Pharmaceuticals S.A.
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
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.
Detailed Description
Not provided
Conditions Module
Conditions
Moderate to Severe Atopic Dermatitis
Keywords
ISB 830, OX40, atopic dermatitis
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
462Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ISB 830 - Part 1 Group 1
Experimental
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
Drug: ISB 830 - Part 1 Group 1
ISB 830 - Part 1 Group 2
Experimental
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
Drug: ISB 830 - Part 1 Group 2
ISB 830 - Part 1 Group 3
Experimental
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
Drug: ISB 830 - Part 1 Group 3
Placebo - Part 1 Group 4
Placebo Comparator
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Drug: Placebo - Part 1 Group 4
ISB 830 - Part 2 Group 5
Experimental
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
Drug: ISB 830 - Part 2 Group 5
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ISB 830 - Part 1 Group 1
Drug
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Baseline, Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16
In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria.
Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
EASI score of ≥12 at screening or ≥16 at baseline.
IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.
Exclusion Criteria:
Pregnant or lactating women.
Prior treatment with ISB 830
Treatment with biologics
Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
Active chronic or acute infection requiring systemic treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Andrea Acocella, MD, MBA
Ichnos Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ichnos Investigational Site 129
Birmingham
Alabama
35209
United States
Ichnos Investigational Site 120
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
During Blinded Treatment Phase, participants received placebo-controlled treatment with ISB 830 administered subcutaneously (SC) for 16 weeks at different dose levels. During the Open-label Treatment Phase, participants received treatment with ISB 830 administered SC every other week (q2w) for 38 weeks.
Recruitment Details
The study was conducted in 4 phases: a Screening phase (28 days before randomization), a Blinded Treatment Phase (up to Week 16), an Open-label Treatment Phase (Week 16 to Week 54), and a Follow-up Phase (Week 54 to Week 66)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Drug: Placebo - Part 2 Group 6
ISB 830 - Part 1 Group 2
Drug
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 2
ISB 830 - Part 1 Group 3
Drug
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 3
Placebo - Part 1 Group 4
Drug
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 1 Group 4
ISB 830 - Part 2 Group 5
Drug
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 2 Group 5
Placebo - Part 2 Group 6
Drug
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 2 Group 6
Baseline, Week 16
Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16
The IGA is an assessment scale used in clinical studies to determine severity of AD based on a 5-point scale ranging from 0 (clear) to 4 (severe/very severe).
Baseline, Week 16
Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Baseline, Week 16
Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16
In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Baseline, Week 16
Percent Change From Baseline in SCORAD Score at Week 16
SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of BSA affected; b) subjective symptom visual analog assessments for pruritis ( 0 [no itching] to 3 [severe itching]) and sleep disturbance (0 [no sleep disturbance] to 3 [severe sleep disturbance]); and c) 6 disease intensity assessments [dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe).](streamdown:incomplete-link)
Baseline, Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
Baseline, Week 16
Change From Baseline in Global Individual Signs Score (GISS) at Week 16
GISS assesses AD lesions for erythema, excoriations, lichenification and infiltration/papulation. Each component is rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe) according to the EASI grading severity. Total score ranges from 0 to 12 (no disease to most severe disease, respectively).
Baseline, Week 16
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16
The HADS is a 14-item questionnaire, with 7 items related to anxiety (HADS-A) and 7 items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each subscale, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Baseline, Week 16
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema).
Baseline, Week 16
Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16
For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent".
Baseline, Week 16
Percentage Change From Baseline in PGA of Disease and Treatment at Week 16
For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent".
Baseline, Week 16
Number of Missed Work or School Days at Week 16
Participants who were employed or enrolled in school were asked to report the number of sick leave and/or missed school days due to AD (eg, versus due to an accident) in the last 4 weeks.
Week 16
Maximum Observed Serum Concentration (Cmax) of ISB 830
Cmax is the maximum concentration of ISB 830 observed in serum
Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on Day 85
Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau)
AUC0-tau is the area under the curve from time zero to the end of the dosing interval of ISB 830.
Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on Day 85
Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16
Participants with ADA were those with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period (up to Week 16). Treatment-emergent ADA referred to percentage of the total number of evaluable participants who were ADA-negative at baseline but developed ADA following biologic drug administration. Treatment-boosted ADA referred to percentage of the total number of evaluable participants who were ADA positive at baseline with at least 4-fold increase in ADA titer after biologic drug administration.
Baseline through Week 16
Clovis
California
93711
United States
Ichnos Investigational Site 105
Rolling Hills Estates
California
90274
United States
Ichnos Investigational Site 106
Bridgeport
Connecticut
06606
United States
Ichnos Investigational Site 146
Danbury
Connecticut
06810
United States
Ichnos Investigational Site 142
Brandon
Florida
33511
United States
Ichnos Investigational Site 143
Fort Myers
Florida
33912
United States
Ichnos Investigational Site 148
Lake City
Florida
32055
United States
Ichnos Investigational Site 141
Lake Worth
Florida
33461
United States
Ichnos Investigational Site 140
Miami
Florida
33156
United States
Ichnos Investigational Site 123
Miami
Florida
33175
United States
Ichnos Investigational Site 147
Ormond Beach
Florida
32174
United States
Ichnos Investigational site 101
Tampa
Florida
33607
United States
Ichnos Investigational Site 135
Tampa
Florida
33612
United States
Ichnos Investigational Site 115
Newnan
Georgia
30263
United States
Ichnos Investigational Site 139
Savannah
Georgia
31406
United States
Ichnos Investigational Site 112
Plainfield
Indiana
46168
United States
Ichnos Investigational Site 125
West Des Moines
Iowa
50265
United States
Ichnos Investigational Site109
New Orleans
Louisiana
70115
United States
Ichnos Investigational Site 126
St Louis
Missouri
63141
United States
Ichnos Investigational Site 144
Las Vegas
Nevada
89120
United States
Ichnos Investigational Site 117
Verona
New Jersey
07044-2946
United States
Glenmark Investigational Site 102
Forest Hills
New York
11375
United States
Ichnos Investigational Site 114
Medford
Oregon
97504-9741
United States
Ichnos Investigational Site 133
Hazleton
Pennsylvania
18201
United States
Ichnos Investigational Site 122
Philadelphia
Pennsylvania
19103
United States
Ichnos Investigational Site 132
Chattanooga
Tennessee
37421
United States
Ichnos Investigational Site 119
Houston
Texas
77004
United States
Ichnos Investigational Site 138
Pflugerville
Texas
78660
United States
Ichnos Investigational Site 116
San Antonio
Texas
78258
United States
Ichnos Investigational Site 110
Waco
Texas
76710
United States
Ichnos Investigational Site 103
Newport News
Virginia
23606-4537
United States
Ichnos Investigational Site 131
Richmond
Virginia
23220
United States
Ichnos Investigational Site 136
Spokane
Washington
99224
United States
Ichnos Investigational Site 202
Calgary
Alberta
T3A 2N1
Canada
Ichnos Investigational Site 203
Surrey
British Columbia
V3V 0C6
Canada
Ichnos Investigational Site 207
Winnipeg
Manitoba
R3M 3Z4
Canada
Ichnos Investigational Site 214
Hamilton
Ontario
L8N 3Z5
Canada
Ichnos Investigational Site 204
Markham
Ontario
L3P 1X2
Canada
Ichnos Investigational Site 206
Ottawa
Ontario
K1G 6C6
Canada
Ichnos Investigational Site 208
Ottawa
Ontario
K2C 3N2
Canada
Ichnos Investigational Site 201
Richmond Hill
Ontario
L4C 9M7
Canada
Ichnos Investigational Site 211
Drummondville
Quebec
QC, J2B 5L
Canada
Ichnos Investigational Site 404
Brno
Brno-město
602 00
Czechia
Ichnos Investigational Site 402
Náchod
Hradec Králové Region
547 01
Czechia
Ichnos Investigational Site 403
Prague
Praha 3
130 00
Czechia
Ichnos Investigational Site 401
Ostrava
702 00
Czechia
Ichnos Investigational Site 405
Pardubice
530 02
Czechia
Ichnos Investigational Site 407
Prague
110 00
Czechia
Ichnos Investigational Site 406
Svitavy
568 02
Czechia
Ichnos Investigational Site 313
Friedrichshafen
Baden-Wurttemberg
88045
Germany
Ichnos Investigational Site 305
Langenau
Baden-Wurttemberg
89129
Germany
Ichnos Investigational Site 311
Erlangen
Bavaria
91054
Germany
Ichnos Investigational Site 314
Osnabrück
Lower Saxony
49074
Germany
Ichnos Investigational Site 322
Bielefeld
North Rhine-Westphalia
33647
Germany
Ichnos Investigational Site 318
Bochum
North Rhine-Westphalia
44793
Germany
Ichnos Investigational Site 302
Dresden
Saxony
01097
Germany
Ichnos Investigational Site 309
Dresden
Saxony
1069
Germany
Ichnos Investigational Site 315
Lübeck
Schleswig-Holstein
23538
Germany
Ichnos Investigational Site 319
Berlin
10117
Germany
Ichnos Investigational Site 304
Berlin
10789
Germany
Ichnos Investigational Site 326
Berlin
14050
Germany
Ichnos Investigational Site 310
Hamburg
22143
Germany
Ichnos Investigational Site 308
Hamburg
22391
Germany
Ichnos Investigational Site 518
Poznan
Greater Poland Voivodeship
60-702
Poland
Ichnos Investigational Site 514
Poznan
Greater Poland Voivodeship
60-848
Poland
Ichnos Investigational Site 502
Krakow
Lesser Poland Voivodeship
30-033
Poland
Ichnos Investigational Site 511
Krakow
Lesser Poland Voivodeship
31-002
Poland
Ichnos Investigational Site 510
Krakow
Lesser Poland Voivodeship
31-011
Poland
Ichnos Investigational Site 501
Krakow
Lesser Poland Voivodeship
31-209
Poland
Ichnos Investigational Site 504
Wroclaw
Lower Silesian Voivodeship
51-124
Poland
Ichnos Investigational Site 509
Warsaw
Masovian Voivodeship
01-817
Poland
Ichnos Investigational Site 521
Warsaw
Masovian Voivodeship
02-625
Poland
Ichnos Investigational Site 512
Warsaw
Masovian Voivodeship
02-758
Poland
Ichnos Investigational Site 506
Warsaw
Masovian Voivodeship
04-141
Poland
Ichnos Investigational Site 517
Iwonicz-Zdrój
Podkarpackie Voivodeship
38-440
Poland
Ichnos Investigational Site 519
Gdynia
Pomeranian Voivodeship
81-338
Poland
Ichnos Investigational Site 520
Gdynia
Pomeranian Voivodeship
81-384
Poland
Ichnos Investigational Site 513
Szczecin
West Pomeranian Voivodeship
71-270
Poland
Ichnos Investigational Site 503
Katowice
40-851
Poland
Ichnos Investigational Site 505
Krakow
31-513
Poland
Ichnos Investigational Site 508
Skarżysko-Kamienna
26-110
Poland
Ichnos Investigational Site 507
Warsaw
02-777
Poland
FG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
FG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
FG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
FG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
FG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
FG00076 subjects
FG00180 subjects
FG00277 subjects
FG00380 subjects
FG00475 subjects
FG00574 subjects
COMPLETED
FG00054 subjects
FG00157 subjects
FG00242 subjects
FG00350 subjects
FG00461 subjects
FG00560 subjects
NOT COMPLETED
FG00022 subjects
FG00123 subjects
FG00235 subjects
FG00330 subjects
FG00414 subjects
FG00514 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00015 subjects
FG00115 subjects
FG00226 subjects
FG00322 subjects
FG004
Others
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0034 subjects
FG004
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Two participants randomized to ISB 830 300 mg q4w group discontinued study without receiving any study drug and were excluded from FAS.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00076
BG00178
BG00277
BG00380
BG00475
BG00574
BG006460
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
BG00040.2± 13.10
BG00136.6± 14.77
BG00238.4± 16.87
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00144
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.72± 7.538
BG00127.49± 6.167
BG002
Baseline Eczema Area and Severity Index (EASI) Score
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity. The EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00030.42± 14.110
BG001
Baseline Severity scoring of Atopic Dermatitis (SCORAD) Score
SCORAD is a composite severity index score. A SCORAD score ranges from 0 (no AD present) to 103 (severe).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00067.50± 14.325
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
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage change
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00051
OG00145
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG000-57.589± 36.2014
OG001-56.734± 32.5395
OG002-38.099± 39.6857
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
OG003
Mixed Models Analysis
= 0.008
LS Mean Difference
-20.192
Standard Error of the Mean
7.4781
2-Sided
95
-34.944
5.439
A linear contrast was used to estimate the treatment difference
Superiority
The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit
Secondary
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16
In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Any participant who received a rescue medication for AD during Part 1, had missed Week 16 assessment, or withdrew before Week 16 was considered Non-responder.
Posted
Number
percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16
The IGA is an assessment scale used in clinical studies to determine severity of AD based on a 5-point scale ranging from 0 (clear) to 4 (severe/very severe).
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Any participant who received a rescue medication for AD during Part 1, had missed Week 16 assessment, or withdrew before Week 16 was considered Non-responder.
Posted
Number
percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Any participant who received a rescue medication for AD during Part 1, had missed Week 16 assessment or withdrew before Week 16 was considered Non-responder.
Posted
Number
percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16
In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Any participant who received a rescue medication for AD during Part 1, had missing Week 16 assessment, or withdrew before Week 16 was considered Nonresponder
Posted
Number
percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Percent Change From Baseline in SCORAD Score at Week 16
SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of BSA affected; b) subjective symptom visual analog assessments for pruritis ( 0 [no itching] to 3 [severe itching]) and sleep disturbance (0 [no sleep disturbance] to 3 [severe sleep disturbance]); and c) 6 disease intensity assessments [dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe).](streamdown:incomplete-link)
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage change
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants analyzed for this outcome measure and 'Number Analyzed' signifies the number of participants analyzed at specified time point.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Change From Baseline in Global Individual Signs Score (GISS) at Week 16
GISS assesses AD lesions for erythema, excoriations, lichenification and infiltration/papulation. Each component is rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe) according to the EASI grading severity. Total score ranges from 0 to 12 (no disease to most severe disease, respectively).
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants analyzed for this outcome measure and 'Number Analyzed' signifies the number of participants analyzed at specified time point.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16
The HADS is a 14-item questionnaire, with 7 items related to anxiety (HADS-A) and 7 items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each subscale, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants analyzed for this outcome measure and 'Number Analyzed' signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Secondary
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema).
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants analyzed for this outcome measure and 'Number Analyzed' signifies the number of participants analyzed for specified time point.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16
For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent".
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants analyzed for this outcome measure and 'Number Analyzed' signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Percentage Change From Baseline in PGA of Disease and Treatment at Week 16
For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent".
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.
Posted
Mean
Standard Deviation
percentage change
Baseline, Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Number of Missed Work or School Days at Week 16
Participants who were employed or enrolled in school were asked to report the number of sick leave and/or missed school days due to AD (eg, versus due to an accident) in the last 4 weeks.
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
days
Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Secondary
Maximum Observed Serum Concentration (Cmax) of ISB 830
Cmax is the maximum concentration of ISB 830 observed in serum
Pharmacokinetic Analysis Set (PKAS) included all participants who received at least 1 dose of ISB 830, did not had any major protocol deviation affecting pharmacokinetic (PK), and for whom at least 1 sample with detectable plasma concentration with known time of dosing and the time of sampling was available. 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliters (µg/mL)
Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on Day 85
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Secondary
Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau)
AUC0-tau is the area under the curve from time zero to the end of the dosing interval of ISB 830.
Pharmacokinetic Analysis Set (PKAS) included all participants who received at least 1 dose of ISB 830, did not had any major protocol deviation affecting pharmacokinetic (PK), and for whom at least 1 sample with detectable plasma concentration with known time of dosing and the time of sampling was available. 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on Day 85
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
ISB 830 300 mg q4w
Secondary
Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16
Participants with ADA were those with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period (up to Week 16). Treatment-emergent ADA referred to percentage of the total number of evaluable participants who were ADA-negative at baseline but developed ADA following biologic drug administration. Treatment-boosted ADA referred to percentage of the total number of evaluable participants who were ADA positive at baseline with at least 4-fold increase in ADA titer after biologic drug administration.
Safety Analysis Set (SAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment they received. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline through Week 16
ID
Title
Description
OG000
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG001
Time Frame
Up to Week 54
Description
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication
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
ISB 830 300 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
0
76
4
76
68
76
EG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
0
78
6
78
56
78
EG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
0
77
4
77
64
77
EG003
Placebo - 1 (Blinded)
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
0
80
1
80
57
80
EG004
Placebo - 1 (Open Label)
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
0
60
2
60
43
60
EG005
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
1
75
1
75
65
75
EG006
Placebo - 2 (Blinded)
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
0
74
0
74
37
74
EG007
Placebo - 2 (Open Label)
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
0
67
2
67
38
67
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG0031 affected80 at risk
EG0040 affected60 at risk
EG0050 affected75 at risk
EG0060 affected74 at risk
EG0070 affected67 at risk
Eye complication associated with device
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Pernicious anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected76 at risk
EG0012 affected78 at risk
EG0026 affected77 at risk
EG0031 affected80 at risk
EG0040 affected60 at risk
EG0053 affected75 at risk
EG0063 affected74 at risk
EG0071 affected67 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0013 affected78 at risk
EG0020 affected77 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0015 affected78 at risk
EG0021 affected77 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 affected76 at risk
EG0015 affected78 at risk
EG0021 affected77 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00016 affected76 at risk
EG00115 affected78 at risk
EG00210 affected77 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0013 affected78 at risk
EG0026 affected77 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00012 affected76 at risk
EG0018 affected78 at risk
EG00213 affected77 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0014 affected78 at risk
EG0024 affected77 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0023 affected77 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected76 at risk
EG0012 affected78 at risk
EG0024 affected77 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0008 affected76 at risk
EG0017 affected78 at risk
EG0024 affected77 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0014 affected78 at risk
EG0023 affected77 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0024 affected77 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG00017 affected76 at risk
EG00124 affected78 at risk
EG00221 affected77 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0024 affected77 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0013 affected78 at risk
EG0022 affected77 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0013 affected78 at risk
EG0021 affected77 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gastrooesophageal sphincter insufficiency
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Reflux gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0022 affected77 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Ear swelling
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blepharitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Chalazion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Eye irritation
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Eyelid margin crusting
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Keratitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Photophobia
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Application site reaction
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Face oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Facial pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Feeling cold
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0013 affected78 at risk
EG0021 affected77 at risk
EG003
Injection site bruising
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site erythema
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0013 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site haematoma
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Injection site induration
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Injection site oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Injection site pruritus
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site rash
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site reaction
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Injection site swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Injection site urticaria
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Feeling hot
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Therapeutic response unexpected
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Food allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Abscess oral
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Bacterial blepharitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Chest wall abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Ear lobe infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Eczema herpeticum
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Eczema impetiginous
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Furuncle
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Herpes ophthalmic
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0023 affected77 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Impetigo
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ophthalmic herpes simplex
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Otitis externa bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Pyuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Skin candida
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Superinfection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Acne pustular
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Asymptomatic COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Bacterial vulvovaginitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Eczema infected
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Enterobiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Genital infection female
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Testicular abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Transfusion related complication
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
Bacterial test positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood pressure increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Cardiac murmur
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Glucose urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0020 affected77 at risk
EG003
Red blood cells urine positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Streptococcus test positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Urinary casts present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Urine leukocyte esterase positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Blood iron decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Haemoglobin urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Platelet count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Protein urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Urine ketone body present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Histamine intolerance
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Ligamentitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Scleroderma
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Aphonia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected78 at risk
EG0022 affected77 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0022 affected77 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Thoracic spinal cord paralysis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected78 at risk
EG0021 affected77 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Haemoglobinuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Cervix inflammation
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Premature menopause
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Uterine cervix stenosis
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Breast inflammation
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ovarian disorder
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Nasal septum disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Reflux laryngitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0022 affected77 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0021 affected77 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected78 at risk
EG0020 affected77 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Photodermatosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Solar urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected78 at risk
EG0020 affected77 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0021 affected77 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected78 at risk
EG0020 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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is mutually agreed upon between the PI and the Sponsor. The sponsor cannot unilaterally extend the embargo.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872
Dermatitis
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
3 subjects
FG0052 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
1 subjects
FG0051 subjects
6 subjects
FG0059 subjects
2 subjects
FG0051 subjects
36.3
± 13.05
BG00437.9± 13.31
BG00536.0± 13.75
BG00637.55± 14.21
41
BG00344
BG00437
BG00547
BG006245
Male
BG00044
BG00134
BG00236
BG00336
BG00438
BG00527
BG006215
2
BG0032
BG0043
BG0050
BG00615
Not Hispanic or Latino
BG00071
BG00175
BG00275
BG00378
BG00472
BG00573
BG006444
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
0
BG0030
BG0040
BG0050
BG0060
Asian
BG0005
BG0014
BG0024
BG0037
BG0042
BG0051
BG00623
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG00013
BG00114
BG0026
BG00315
BG0046
BG0054
BG00658
White
BG00058
BG00159
BG00265
BG00358
BG00466
BG00569
BG006375
More than one race
BG0000
BG0011
BG0022
BG0030
BG0040
BG0050
BG0063
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
26.32
± 6.199
BG00327.20± 6.608
BG00426.03± 5.167
BG00526.50± 5.434
BG00627.05± 6.27
33.84
± 14.910
BG00228.42± 11.602
BG00330.65± 13.173
BG00429.86± 13.223
BG00531.81± 14.340
BG00630.84± 13.630
69.09
± 14.284
BG00266.22± 12.408
BG00366.12± 12.658
BG00466.40± 12.300
BG00567.66± 13.560
BG00667.16± 13.250
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
42
OG00453
OG00551
-42.142
± 38.1945
OG004-59.737± 27.1176
OG005-43.252± 41.2404
OG001
OG003
Mixed Models Analysis
= 0.061
LS Mean Difference
-14.439
Standard Error of the Mean
7.6622
2-Sided
95
-29.552
0.674
A linear contrast was used to estimate the treatment difference
Superiority
The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.
OG002
OG003
Mixed Models Analysis
= 0.691
LS Mean Difference
3.144
Standard Error of the Mean
7.8864
2-Sided
95
-12.410
18.698
A linear contrast was used to estimate the treatment difference.
Superiority
The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.
OG004
OG005
The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.
Mixed Models Analysis
= 0.008
LS Mean Difference
-17.199
Standard Error of the Mean
6.4090
2-Sided
95
-29.895
-4.503
A linear contrast was used to estimate the treatment difference.
Superiority
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Title
Measurements
OG00023.7
OG00120.5
OG00211.7
OG00311.3
OG00425.3
OG00518.9
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Title
Measurements
OG00013.2
OG00110.3
OG0026.5
OG0035.0
OG00412.0
OG0055.4
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Title
Measurements
OG0007.9
OG00111.5
OG0025.2
OG00310.0
OG00413.3
OG0059.5
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Title
Measurements
OG00048.7
OG00134.6
OG00227.3
OG00327.5
OG00444.0
OG00533.8
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00051
OG00145
OG00239
OG00342
OG00453
OG00551
Title
Denominators
Categories
Title
Measurements
OG000-26.519± 18.1662
OG001-26.108± 21.4476
OG002-18.405± 15.8756
OG003-19.440± 17.4296
OG004-27.401± 14.4471
OG005-18.847± 14.4472
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
ParticipantsOG00475
ParticipantsOG00574
Title
Measurements
OG00015.2± 6.80
OG00115.4± 7.14
OG00214.3± 7.18
OG003
Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
ParticipantsOG00475
ParticipantsOG00574
Title
Measurements
OG0009.1± 1.81
OG0019.4± 1.71
OG0029.1± 1.71
OG003
Change at Week 16
ParticipantsOG00051
ParticipantsOG00145
ParticipantsOG00239
ParticipantsOG00342
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
HADS-A Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
ParticipantsOG00475
ParticipantsOG00574
Title
Measurements
OG0006.1± 4.47
OG0016.1± 4.82
OG0026.1± 4.15
OG003
HADS-D Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
HADS-A Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
HADS-D Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
ParticipantsOG00475
ParticipantsOG00574
Title
Measurements
OG00020.2± 5.78
OG00120.9± 5.56
OG00219.8± 5.27
OG003
Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00076
OG00178
OG00277
OG00380
OG00475
OG00574
Title
Denominators
Categories
PGA of Disease Baseline
ParticipantsOG00076
ParticipantsOG00178
ParticipantsOG00277
ParticipantsOG00380
ParticipantsOG00475
ParticipantsOG00574
Title
Measurements
OG0002.0± 0.89
OG0011.9± 0.84
OG0022.1± 0.97
OG003
PGA of Treatment Baseline
ParticipantsOG00070
ParticipantsOG00163
ParticipantsOG00265
ParticipantsOG00369
PGA of Disease Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
PGA of Treatment Change at Week 16
ParticipantsOG00050
ParticipantsOG00141
ParticipantsOG00237
ParticipantsOG00341
OG001
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00051
OG00144
OG00239
OG00342
OG00452
OG00551
Title
Denominators
Categories
PGA of Disease: Percent Change at Week 16
ParticipantsOG00051
ParticipantsOG00144
ParticipantsOG00239
ParticipantsOG00342
ParticipantsOG00452
ParticipantsOG00551
Title
Measurements
OG00072.2± 93.51
OG00173.3± 114.18
OG00233.3± 87.25
OG003
PGA of Treatment: Percent Change at Week 16
ParticipantsOG00050
ParticipantsOG00141
ParticipantsOG00237
ParticipantsOG00341
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00044
OG00135
OG00231
OG00332
OG00434
OG00538
Title
Denominators
Categories
Title
Measurements
OG0001.2± 3.73
OG0010.5± 0.92
OG0020.5± 1.26
OG0030.5± 1.29
OG0044.9± 14.92
OG0051.4± 5.31
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG0033
Title
Denominators
Categories
Day 1
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG0033
Title
Measurements
OG00046.98± 46.5
OG00149.95± 33.1
OG00216.62± 32.6
OG003
Day 85
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0032
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
Units
Counts
Participants
OG00012
OG00114
OG00213
OG0032
Title
Denominators
Categories
Day 1
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG0031
Title
Measurements
OG00012170± 49.9
OG00120340± 34.1
OG0026671± 40.2
OG003
Day 85
ParticipantsOG00010
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0032
ISB 830 300 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG002
ISB 830 75 mg q4w
Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG003
Placebo - 1
Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG004
ISB 830 600 mg q2w
Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
OG005
Placebo - 2
Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.