A Study of Subcutaneous Risankizumab Injection for Pediat... | NCT04435600 | Trialant
NCT04435600
Sponsor
AbbVie
Status
Completed
Last Update Posted
May 20, 2025Actual
Enrollment
139Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Risankizumab
Ustekinumab
Countries
United States
Canada
Germany
Japan
Poland
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04435600
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M19-977
Secondary IDs
ID
Type
Description
Link
2023-504156-10-00
Other Identifier
EU CT
Brief Title
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Official Title
A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Acronym
OptIMMize-1
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 14, 2020Actual
Primary Completion Date
Feb 12, 2024Actual
Completion Date
Oct 15, 2024Actual
First Submitted Date
Jun 16, 2020
First Submission Date that Met QC Criteria
Jun 16, 2020
First Posted Date
Jun 17, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2025
Results First Submitted that Met QC Criteria
May 19, 2025
Results First Posted Date
May 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 9, 2025
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 20, 2025Actual
Last Update Submitted Date
May 19, 2025
Last Update Posted Date
May 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms.
Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.
Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive;
Period A: Risankizumab or ustekinumab based on body weight followed by;
Period B: Risankizumab or no treatment.
Period C: Re-treatment with risankizumab (if needed).
Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight.
Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 > 18 will receive risankizumab based on body weight).
Around 132 participants will be enrolled in approximately 50 sites worldwide.
Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.
Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.
Part 2:
Period A: Risankizumab or ustekinumab for 16 weeks.
Period B: Risankizumab or no treatment for 36 weeks.
Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.
There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Plaque Psoriasis
Risankizumab
Ustekinumab
Psoriasis
Biologic
ABBV-066
SKYRIZI
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
139Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Risankizumab Dose A
Experimental
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Drug: Risankizumab
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Experimental
Participants age 12 to less than 18 will receive:
Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Risankizumab Dose A or B based on body weight for 24 weeks.
Drug: Risankizumab
Drug: Ustekinumab
Part 2: Risankizumab Dose A/B
Experimental
Participants age 12 to less than 18 will receive:
Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare.
Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Drug: Risankizumab
Part 3: Risankizumab Dose A/B
Experimental
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Drug: Risankizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Risankizumab
Drug
Subcutaneous Injection
Part 1: Risankizumab Dose A
Part 2: Risankizumab Dose A/B
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
At Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.
Exclusion Criteria:
- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UAB Department of Dermatology /ID# 218834
Birmingham
Alabama
35233
United States
First OC Dermatology /ID# 217733
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
A total of 139 participants were sequentially enrolled in the trial. Two participants in Part 4 were excluded from the Intent To Treat (ITT) Population because they were not from the same age cohort as the population studied in Part 4 (children) but were added to Part 4 for administrative reasons (closure of Part 2 enrollment).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
FG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Periods
Title
Milestones
Reasons Not Completed
Part 1 (Baseline to Week 40)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 16, 2023
Apr 10, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Outcomes Assessor
Part 4: Risankizumab Dose A/B
Experimental
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).
Drug: Risankizumab
Part 3: Risankizumab Dose A/B
Part 4: Risankizumab Dose A/B
SKYRIZI
ABBV-066
Ustekinumab
Drug
Subcutaneous Injection
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving >= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of >=4.
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Fountain Valley
California
92708
United States
Integrative Skin Science and Research /ID# 221741
Sacramento
California
95815
United States
University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
San Diego
California
92123
United States
Rybear, Inc /ID# 223164
Fort Lauderdale
Florida
33316-1952
United States
Solutions Through Adv Rch /ID# 217936
Jacksonville
Florida
32256
United States
Olympian Clinical Research- St. Petersburg /ID# 217941
St. Petersburg
Florida
33709-1405
United States
Advanced Clinical Research Institute /ID# 222706
Tampa
Florida
33607
United States
University Dermatology and Vein Clinic, LLC /ID# 222778
Darien
Illinois
60561
United States
Duplicate_Arlington Dermatology /ID# 217472
Rolling Meadows
Illinois
60008
United States
Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738
Reno
Nevada
89052
United States
Duplicate_Forest Hills Dermatology Group /ID# 227941
Kew Gardens
New York
11415
United States
Univ Hosp Cleveland /ID# 228483
Cleveland
Ohio
44106
United States
The Ohio State University /ID# 217808
Columbus
Ohio
43210
United States
Apex Clinical Research Center /ID# 228537
Mayfield Heights
Ohio
44124
United States
Vital Prospects Clinical Research Institute, PC /ID# 217960
Guys and St Thomas NHS Foundation Trust /ID# 227224
London
Greater London
SE1 9RT
United Kingdom
Chelsea and Westminster Hospital /ID# 227231
London
Greater London
SW10 9NH
United Kingdom
NHS Greater Glasgow and Clyde /ID# 227226
Glasgow
Scotland
G12 0XH
United Kingdom
Frimley Health NHS Foundation Trust /ID# 229525
Camberley
Surrey
GU16 7UJ
United Kingdom
FG002
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
FG003
Part 2 Period A: Ustekinumab; Period B: Risankizumab
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
FG004
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injectionat Weeks 16, 28, and 40.
FG005
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
FG006
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
FG007
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
FG008
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
FG009
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
FG00012 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00012 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Part 2: Period A (Baseline to Week 16)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00128 subjects
FG00254 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG00128 subjects
FG00253 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Part 2: Period B (Week 16 to Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00328 subjects
FG00410 subjects
FG00522 subjects
FG00621 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00328 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2: Period C (Week 52 to Week 68)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0078 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 3 (Baseline to Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00813 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 4 (Baseline to Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00932 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Intent to Treat (ITT) Population included all enrolled participants in from Parts 1, 3, and 4, and all randomized participants from Part 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
BG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
BG002
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
BG003
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
BG004
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00128
BG00254
BG00313
BG00430
BG005137
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
6 to < 9 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Psoriasis Area and Severity Index (PASI) Score
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree).
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Title
Measurements
BG00021.43± 8.124
BG001
Static Physician Global Assessment (sPGA) Category
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes.
Count of Participants
Participants
Title
Denominators
Categories
0
Title
Measurements
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
OG003
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
OG004
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Units
Counts
Participants
OG00012
OG00128
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG00083.3(51.6 to 97.9)
OG00185.7(67.3 to 96.0)
OG00285.2(72.9 to 93.4)
OG003
Primary
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Primary
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Secondary
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Secondary
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Secondary
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
ID
Title
Description
OG000
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
OG001
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG002
Part 2 Period A: Risankizumab
Secondary
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
ID
Title
Description
OG000
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG001
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Secondary
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
ID
Title
Description
OG000
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG001
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Secondary
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Secondary
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
ID
Title
Description
OG000
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG001
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Units
Counts
Participants
Secondary
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
ID
Title
Description
OG000
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)
The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving >= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of >=4.
The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
ID
Title
Description
OG000
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
OG001
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Time Frame
All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
Description
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
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
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection on weeks 0, 4, 16, 28, and 40.
0
12
0
12
6
12
EG001
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
0
54
0
54
21
54
EG002
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
0
28
0
28
11
28
EG003
Part 2 Period A: Ustekinumab; Period B: Risankizumab
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
0
28
1
28
19
28
EG004
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
0
10
1
10
8
10
EG005
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
0
22
0
22
13
22
EG006
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
0
21
1
21
11
21
EG007
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
0
8
0
8
4
8
EG008
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
0
13
0
13
6
13
EG009
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
0
32
0
32
23
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
EOSINOPHILIC OESOPHAGITIS
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected22 at risk
EG0061 events1 affected21 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected32 at risk
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG0032 events1 affected28 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected22 at risk
EG0060 events0 affected21 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected32 at risk
CONSTIPATION
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected28 at risk
EG003
CHILLS
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
INJECTION SITE HAEMATOMA
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PAIN
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PYREXIA
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
HYPERTRANSAMINASAEMIA
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
BACTERIAL VAGINOSIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
BODY TINEA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected28 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events5 affected54 at risk
EG0022 events2 affected28 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
LICE INFESTATION
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG00117 events10 affected54 at risk
EG0024 events4 affected28 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
SKIN CANDIDA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
TINEA VERSICOLOUR
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected28 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
SKIN INJURY
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0014 events3 affected54 at risk
EG0023 events3 affected28 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
VULVOVAGINAL PRURITUS
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected28 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
POST INFLAMMATORY PIGMENTATION CHANGE
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected28 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected28 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
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.