BI 655066 (Risankizumab) Compared to Placebo and Active C... | NCT02684370 | Trialant
NCT02684370
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jul 30, 2021Actual
Enrollment
560Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
risankizumab
placebo for risankizumab
ustekinumab
placebo for ustekinumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02684370
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-008
Secondary IDs
ID
Type
Description
Link
2014-005117-23
EudraCT Number
1311.3
Other Identifier
Boehringer Ingelheim
Brief Title
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official Title
BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2021
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
Feb 2016Actual
Primary Completion Date
Dec 2016Actual
Completion Date
Sep 2017Actual
First Submitted Date
Feb 16, 2016
First Submission Date that Met QC Criteria
Feb 16, 2016
First Posted Date
Feb 18, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 3, 2019
Results First Submitted that Met QC Criteria
May 30, 2019
Results First Posted Date
Jun 18, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 30, 2017
Certification/Extension First Submitted that Passed QC Review
Nov 30, 2017
Certification/Extension First Posted Date
Dec 5, 2017Actual
Last Update Submitted Date
Jul 28, 2021
Last Update Posted Date
Jul 30, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Boehringer Ingelheim
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Detailed Description
Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
ustekinumab
Dermatologic Agents
ABBV-066
BI 655066
risankizumab
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
560Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo (Part A)
Placebo Comparator
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Drug: placebo for risankizumab
Drug: placebo for ustekinumab
Ustekinumab (Part A)
Active Comparator
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Drug: placebo for risankizumab
Drug: ustekinumab
Risankizumab (Part A)
Experimental
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Drug: risankizumab
Drug: placebo for ustekinumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
risankizumab
Drug
Risankizumab administered by subcutaneous (SC) injection
Risankizumab (Part A)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Male or female patients with age ≥18 years at screening.
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):
Have an involved body surface area (BSA) ≥10% and
Have a Psoriasis Area and Severity Index (PASI) score ≥12 and
Have a static Physician Global Assessment (sPGA) score of ≥3.
Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
Exclusion criteria:
Patients with:
non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment
Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.
A total of 560 subjects were enrolled; 54 subjects failed screening and are excluded from the analyses.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
FG001
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
Intent-to-treat (ITT) population: All participants who were randomized at Week 0
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Canada
Czechia
France
Germany
Japan
South Korea
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
ABBV-066
BI 655066
SKYRIZI
placebo for risankizumab
Drug
Placebo for risankizumab administered by subcutaneous (SC) injection
Placebo (Part A)
Ustekinumab (Part A)
ustekinumab
Drug
Ustekinumab administered by subcutaneous (SC) injection
Ustekinumab (Part A)
placebo for ustekinumab
Drug
Placebo for ustekinumab administered by subcutaneous (SC) injection
Placebo (Part A)
Risankizumab (Part A)
Week 16
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Week 16
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Week 16
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Week 16
Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Week 16
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 16
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Week 16
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 16
Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Week 52
Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Week 52
Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 52
Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Week 12
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 12
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Week 16
PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
Baseline, Week 16
Derived
Strober B, Armstrong A, Rubant S, Patel M, Wu T, Photowala H, Crowley J. Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders. J Dermatolog Treat. 2022 Nov;33(7):2991-2996. doi: 10.1080/09546634.2022.2095328. Epub 2022 Jul 31.
Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
Augustin M, Lambert J, Zema C, Thompson EHZ, Yang M, Wu EQ, Garcia-Horton V, Geng Z, Valdes JM, Joshi A, Gordon KB. Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1344-1353. doi: 10.1001/jamadermatol.2020.3617.
Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
FG002
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
FG003
Placebo/Risankizumab (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
FG004
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
FG005
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
FG000102 subjects
FG001100 subjects
FG002304 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00098 subjects
FG00199 subjects
FG002299 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject Withdrawal
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00397 subjects1 participant who received placebo in Part A did not receive a dose of study drug in Part B
FG00499 subjectsParticipants who received ustekinumab in Part A received ustekinumab in Part B
FG005297 subjects2 participants who received risankizumab in Part A did not receive a dose of study drug in Part B
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00395 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-to-treat (ITT) population: All participants who were randomized at Week 0.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
BG001
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
BG002
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000102
BG001100
BG002304
BG003506
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
BG00049.3± 13.63
BG00146.5± 13.42
BG00248.3± 13.39
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00130
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00112
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0012
BG002
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 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0004.9
OG00175.3
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
OG001
Cochran-Mantel-Haenszel
<0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
70.3
2-Sided
95
64.0
76.7
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Primary
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) SC at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
OG001
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Secondary
Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
OG001
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
OG001
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
Secondary
Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
ITT population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
ITT population. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one post-baseline PSS observation on or prior to Week 16.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
Description
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last 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
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
0
102
3
102
16
102
EG001
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
0
100
8
100
16
100
EG002
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
0
304
7
304
45
304
EG003
Placebo/Risankizumab (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
0
97
3
97
25
97
EG004
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
0
99
4
99
36
99
EG005
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
0
297
16
297
75
297
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG0030 events0 affected97 at risk
EG0040 events0 affected99 at risk
EG0050 events0 affected297 at risk
Angina unstable
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Prinzmetal angina
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Chest pain
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Schizoaffective disorder
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected102 at risk
EG0010 events0 affected100 at risk
EG0020 events0 affected304 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 events2 affected102 at risk
EG0016 events6 affected100 at risk
EG00220 events17 affected304 at risk
EG00310 events8 affected97 at risk
EG004
Urinary tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected102 at risk
EG0012 events2 affected100 at risk
EG0021 events1 affected304 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0007 events6 affected102 at risk
EG0018 events6 affected100 at risk
EG00224 events20 affected304 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0002 events2 affected102 at risk
EG0012 events2 affected100 at risk
EG0029 events9 affected304 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0006 events6 affected102 at risk
EG0011 events1 affected100 at risk
EG0020 events0 affected304 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
AbbVie
800-633-9110
abbvieclinicaltrials@abbvie.com
ID
Term
D011565
Psoriasis
D012871
Skin Diseases
D017444
Skin Diseases, Papulosquamous
Ancestor Terms
ID
Term
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000601773
risankizumab
D000069549
Ustekinumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
94 subjects
FG005289 subjects
5 subjects
FG0058 subjects
0 subjects
FG0042 subjects
FG0051 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0055 subjects
Subject Withdrawal
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0052 subjects
48.1
± 13.45
92
BG003145
Male
BG00079
BG00170
BG002212
BG003361
23
BG00347
Not Hispanic or Latino
BG00090
BG00188
BG002281
BG003459
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
7
BG00311
Asian
BG00028
BG00122
BG00286
BG003136
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0021
BG0032
Black or African American
BG0001
BG0011
BG00210
BG00312
White
BG00071
BG00174
BG002200
BG003345
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0007.8
OG00187.8
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
OG001
Cochran-Mantel-Haenszel
<0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
79.9
2-Sided
95
73.5
86.3
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0002.0
OG00136.8
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
OG001
Cochran-Mantel-Haenszel
<0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
34.7
2-Sided
95
28.6
40.8
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0000
OG00135.9
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
35.5
2-Sided
95
30.0
41.0
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0007.8
OG00165.8
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
57.9
2-Sided
95
50.4
65.3
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
OG000102
OG001304
Title
Denominators
Categories
Title
Measurements
OG0002.0
OG00129.3
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
27.1
2-Sided
95
21.2
32.9
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00042.0
OG00175.3
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
33.5
2-Sided
95
22.7
44.3
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00063.0
OG00187.8
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
25.1
2-Sided
95
15.2
35.0
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00012.0
OG00135.9
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
23.8
2-Sided
95
15.5
32.1
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00014.0
OG00136.8
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
22.9
2-Sided
95
14.3
31.6
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00044.0
OG00181.9
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
OG001
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
38.3
2-Sided
95
27.9
48.6
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000304
OG001100
Title
Denominators
Categories
Title
Measurements
OG00021.0
OG00156.3
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
35.1
2-Sided
95
25.7
44.6
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00021.0
OG00157.6
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
36.5
2-Sided
95
27.0
45.9
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00070.0
OG00186.8
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
17.0
2-Sided
95
7.4
26.6
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00065.0
OG00182.2
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
17.3
2-Sided
95
7.3
27.3
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG000100
OG001304
Title
Denominators
Categories
Title
Measurements
OG00043.0
OG00165.8
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
OG001
Cochran-Mantel-Haenszel
< 0.001
Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.
adjusted difference in percentage
23.0
2-Sided
95
11.9
34.0
95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.
Other
Units
Counts
Participants
OG00083
OG001251
Title
Denominators
Categories
Title
Measurements
OG0000.157± 0.3476
OG001-5.608± 0.2254
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
OG001
P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).