A Multicenter, Randomized, Double-Blind, Placebo Controll... | NCT03398148 | Trialant
NCT03398148
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jan 16, 2025Actual
Enrollment
1,558Actual
Phase
Phase 2Phase 3
Conditions
Ulcerative Colitis (UC)
Interventions
risankizumab IV
placebo for risankizumab
risankizumab SC
Countries
United States
Argentina
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czechia
Denmark
Egypt
France
Germany
Greece
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Poland
Portugal
Puerto Rico
Romania
Russia
Serbia
Singapore
Slovakia
Slovenia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03398148
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-067
Secondary IDs
ID
Type
Description
Link
2016-004677-40
EudraCT Number
Brief Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jan 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
Mar 7, 2018Actual
Primary Completion Date
Nov 9, 2022Actual
Completion Date
May 11, 2023Actual
First Submitted Date
Jan 8, 2018
First Submission Date that Met QC Criteria
Jan 8, 2018
First Posted Date
Jan 12, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 9, 2024
Results First Submitted that Met QC Criteria
Jan 15, 2025
Results First Posted Date
Jan 16, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 25, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jan 16, 2025Actual
Last Update Submitted Date
Jan 15, 2025
Last Update Posted Date
Jan 16, 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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.
The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis (UC)
Keywords
ABBV-066
BI 655066
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,558Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Substudy 1, Induction Period 1: Double-blind Placebo IV
Placebo Comparator
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: placebo for risankizumab
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Experimental
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
Drug: risankizumab IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Experimental
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Drug: risankizumab IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Experimental
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
Drug: risankizumab IV
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Experimental
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
risankizumab IV
Drug
risankizumab intravenous (IV) infusion
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.
Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement is defined as endoscopy subscore of 0 or 1.
Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
Exclusion Criteria:
Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
Participant receiving prohibited medications and treatment.
Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
Participant with currently known complications of UC (e.g., megacolon).
No known active Coronavirus Disease - 2019 (COVID-19) infection.
Panaccione R, Melmed GY, Drobne D, Kaur M, Danese S, Hisamatsu T, Kalabic J, Chen S, Cheng L, Duan WR, Shah S, Louis E. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment. Clin Gastroenterol Hepatol. 2026 May;24(5):1424-1433. doi: 10.1016/j.cgh.2025.09.007. Epub 2025 Sep 13.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
This study was comprised of 2 SubStudies, each had 2 Periods.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
FG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Periods
Title
Milestones
Reasons Not Completed
Substudy 1 Period 1
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
Dec 16, 2022
May 9, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
American Samoa
Australia
Hungary
Submission Tracking
Estimated Results First Submitted Date
Not provided
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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: risankizumab IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Experimental
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
Substudy 2, Induction Period 1: Double-blind Placebo IV
Placebo Comparator
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: placebo for risankizumab
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Experimental
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Drug: risankizumab IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Experimental
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Experimental
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
ABBV-066
BI 655066
placebo for risankizumab
Drug
placebo for risankizumab
Substudy 1, Induction Period 1: Double-blind Placebo IV
Substudy 2, Induction Period 1: Double-blind Placebo IV
risankizumab SC
Drug
risankizumab subcutaneous (SC) injection
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
ABBV-066
BI 655066
Week 12
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement.
Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Week 12
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical response per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Week 12
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
Clinical response per Partial Adapted Mayo Score (without endoscopy).
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score >= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Week 4
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission was defined as endoscopy subscore of 0.
Week 12
Sub-Study 1: Percentage of Participants With Hospitalization
Participants with an event that results in admission to the hospital.
Mucosal healing defined as endoscopic and histologic remission.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 12
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties).
It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity.
Baseline Through Week 12
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Baseline Through Week 12
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Baseline Through Week 12
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Baseline through Week 12
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale.
0 = not at all
= a little bit
= somewhat
= quite a bit
= very much
The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Baseline Through Week 12
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries
Participants who underwent surgery related to UC.
Through Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical Response is defined as a decrease from baseline in the Adapted Mayo Score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Week 12
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic Improvement is defined as an endoscopic subscore of 0 or 1.
Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Histologic-Endoscopic Mucosal Improvement is defined as an endoscopic subscore of 0 or 1 without evidence of friability and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers).
The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 12
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission per endoscopy subscore.
Endoscopic Remission: endoscopic subscore = 0.
Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4
Clinical response per Partial Adapted Mayo Score (without endoscopy).
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical Response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo Score ≥ 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Week 4
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day.
Week 12
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day.
Week 12
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
Mucosal healing defined as endoscopic and histologic remission.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Week 12
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale.
0 = not at all
= a little bit
= somewhat
= quite a bit
= very much
The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Baseline to Week 12
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Baseline to Week 12
Sub-Study 2: Occurrence of UC-related Hospitalizations
Participants with an UC-related event that results in admission to the hospital.
Baseline Through Week 12
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Percentage of participants who reported no nocturnal bowel movements.
Week 12
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Percentage of participants who reported no tenesmus.
Week 12
Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week
Change in number of fecal incontinence episodes per week.
Baseline to Week 12
Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms
Change from baseline in number of days per week with sleep interrupted due to UC symptoms.
Sahlgrenska University Hospital Molndal /ID# 202843
Mölndal
Västra Götaland County
431 80
Sweden
Danderyds sjukhus AB /ID# 202035
Stockholm
182 88
Sweden
Universitatsspital Zurich /ID# 202910
Zurich
Canton of Zurich
8091
Switzerland
Inselspital, Universitätsspital Bern /ID# 202911
Bern
3010
Switzerland
Chung Shan Medical University Hospital /ID# 163651
Taichung
40201
Taiwan
China Medical University Hospital /ID# 160189
Taichung
40447
Taiwan
Taichung Veterans General Hospital /ID# 163649
Taichung
40705
Taiwan
National Taiwan University Hospital /ID# 162187
Taipei
100
Taiwan
Taipei Veterans General Hosp /ID# 163650
Taipei
11217
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222877
Taoyuan City
333
Taiwan
Acibadem Kozyatagi Hospital /ID# 213276
Kadıköy
Istanbul
34742
Turkey (Türkiye)
Erciyes University Medical Fac /ID# 171291
Melikgazi
Kayseri
38030
Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 167210
Ankara
06590
Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 203981
Battalgazi/malatya
44280
Turkey (Türkiye)
Uludag University Medical Faculty /ID# 204182
Bursa
16059
Turkey (Türkiye)
Fırat University Medical Facul /ID# 171292
Elâzığ
23100
Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207
Istanbul
34098
Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293
Istanbul
34899
Turkey (Türkiye)
Sisli Etfal Train & Res Hosp /ID# 171409
Şişli
34371
Turkey (Türkiye)
CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367
Ivano-Frankivsk
76018
Ukraine
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350
Kherson
73000
Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 224348
Kyiv
01030
Ukraine
Medical Center "OK!Clinic+" /ID# 205482
Kyiv
02091
Ukraine
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343
Kyiv
04073
Ukraine
Royal Devon University Healthcare NHS Foundation Trust /ID# 157587
Exeter
Devon
EX2 5DW
United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 210813
Southampton
Hampshire
SO16 6YD
United Kingdom
Barts Health NHS Trust /ID# 157590
London
London, City of
E1 2ES
United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202770
Barnsley
S75 2EP
United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 158040
Cambridge
CB2 0QQ
United Kingdom
NHS Lothian /ID# 208802
Edinburgh
EH3 9HE
United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 203858
Liverpool
L7 8XP
United Kingdom
King's College Hospital NHS Foundation Trust /ID# 158766
London
SE5 9RS
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041
Newcastle upon Tyne
NE7 7DN
United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 208378
Tooting
SW17 0QT
United Kingdom
Derived
Reinisch W, Loftus EV Jr, Schreiber S, Rubin DT, Louis E, Hecht PM, Barrachina EM, Kalabic J, Vladea R, Sharma D, Duan WR, Zhang Y, Panaccione R. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis. J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.
Panaccione R, Louis E, Colombel JF, D'Haens G, Peyrin-Biroulet L, Dubinsky M, Takeuchi K, Rubin DT, Kalabic J, Chien KB, Chen S, Cheng L, Zhang Y, Duan WR, Vladea R, Hecht PM, Morisset P, Schreiber S, Ferrante M. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis. 2025 Jan 11;19(1):jjaf005. doi: 10.1093/ecco-jcc/jjaf005.
Thakre N, Goebel A, Winzenborg I, Suleiman AA, D'Cunha R, Mensing S, Liu W, Pang Y. Population Pharmacokinetic and Exposure-Response Modeling to Inform Risankizumab Dose Selection in Patients With Ulcerative Colitis. Clin Pharmacol Ther. 2024 Sep;116(3):847-857. doi: 10.1002/cpt.3330. Epub 2024 Jun 11.
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
FG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
FG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
FG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
FG005
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
FG006
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
FG007
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
FG008
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
FG009
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
FG010
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
FG011
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
FG012
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
FG013
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
FG014
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
FG00060 subjects
FG00161 subjects
FG00261 subjects
FG00358 subjects
FG004341 subjects341 enrolled, 340 treated
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG00053 subjects
FG00155 subjects
FG00258 subjects
FG00357 subjects
FG004306 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0007 subjects
FG0016 subjects
FG0023 subjects
FG0031 subjects
FG00435 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0048 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
WITHDREW CONSENT
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Enrolled but not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Substudy 1 Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00572 subjects
FG00670 subjects70 enrolled, 69 treated
FG00736 subjects
FG00837 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Substudy 2 Period 1
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG009325 subjects
FG010652 subjects652 enrolled, 650 treated.
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Substudy 2 Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG01171 subjects
FG01271 subjects71 enrolled; 70 treated
FG01368 subjects
FG014174 subjects174 enrolled; 173 treated
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Includes all enrolled subjects that received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
BG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
BG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
BG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
BG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
BG005
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
BG006
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00161
BG00261
BG00358
BG004340
BG005325
BG006650
BG0071555
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Population includes subjects who received at least one dose of study drug.
Mean
Standard Deviation
years
Title
Denominators
Categories
Substudy 1
ParticipantsBG00060
ParticipantsBG00161
ParticipantsBG00261
ParticipantsBG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Age Group
ParticipantsBG00060
ParticipantsBG00161
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00161
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00161
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00161
ParticipantsBG002
Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
Population includes subjects who received at least one dose of study drug and had available data for analysis.
Mean
Standard Deviation
Adapted Mayo Score 0 - 9
Title
Denominators
Categories
Substudy 1 - ITT1A Population
ParticipantsBG00060
ParticipantsBG001
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
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.
ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Substudy 1.
ITT1B includes all the additional subjects who received at least one dose of risankizumab 1800 mg IV treatment group after 240 subjects were randomized during Induction Period 1 from Substudy 1.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0017
OG0026
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, > 7).
0.0324
P-value ≤ 0.05
Adjusted Risk Difference
9.6
2-Sided
90
2.2
17.0
Risk difference = (risankizumab - Placebo)
Superiority
Primary
Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.
ITT2 population.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement is defined as endoscopy subscore of 0 or 1.
Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement.
Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
No data was collected.
Posted
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical response per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Secondary
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
Clinical response per Partial Adapted Mayo Score (without endoscopy).
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score >= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Week 4
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Secondary
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission was defined as endoscopy subscore of 0.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Percentage of Participants With Hospitalization
Participants with an event that results in admission to the hospital.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
Mucosal healing defined as endoscopic and histologic remission.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Secondary
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties).
It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity.
Includes ITT1A and ITT1B participants with data available for analysis.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Includes ITT1A and ITT1B participants with data available for analysis.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Secondary
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Includes ITT1A and ITT1B participants with data available for analysis.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Includes ITT1A and ITT1B participants with data available for analysis.
Posted
Least Squares Mean
Standard Error
unites on a scale
Baseline through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale.
0 = not at all
= a little bit
= somewhat
= quite a bit
= very much
The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Includes ITT1A and ITT1B participants with data available for analysis.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Secondary
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries
Participants who underwent surgery related to UC.
Includes ITT1A and ITT1B populations.
Posted
Count of Participants
Participants
Through Week 12
ID
Title
Description
OG000
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical Response is defined as a decrease from baseline in the Adapted Mayo Score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic Improvement is defined as an endoscopic subscore of 0 or 1.
Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Histologic-Endoscopic Mucosal Improvement is defined as an endoscopic subscore of 0 or 1 without evidence of friability and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers).
The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission per endoscopy subscore.
Endoscopic Remission: endoscopic subscore = 0.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4
Clinical response per Partial Adapted Mayo Score (without endoscopy).
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical Response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo Score ≥ 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
Mucosal healing defined as endoscopic and histologic remission.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Secondary
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale.
0 = not at all
= a little bit
= somewhat
= quite a bit
= very much
The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Includes ITT2 participants with data available for analysis.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline to Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Secondary
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Includes ITT2 participants with data available for analysis.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline to Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Secondary
Sub-Study 2: Occurrence of UC-related Hospitalizations
Participants with an UC-related event that results in admission to the hospital.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline Through Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Percentage of participants who reported no nocturnal bowel movements.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Percentage of participants who reported no tenesmus.
ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week
Change in number of fecal incontinence episodes per week.
Includes ITT2 participants with data available for analysis.
Posted
Least Squares Mean
95% Confidence Interval
Fecal Incontinence Episodes/ week
Baseline to Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Secondary
Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms
Change from baseline in number of days per week with sleep interrupted due to UC symptoms.
Includes ITT2 participants with data available for analysis.
Posted
Least Squares Mean
95% Confidence Interval
days
Baseline to Week 12
ID
Title
Description
OG000
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
OG001
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG000
Time Frame
In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
Description
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
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
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in that arm.
0
59
6
59
14
59
EG001
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in this arm.
0
62
6
62
13
62
EG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
0
61
4
61
12
61
EG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
0
58
5
58
12
58
EG004
Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
0
341
25
341
76
341
EG005
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
0
36
3
36
11
36
EG006
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
0
37
1
37
6
37
EG007
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in that arm.
0
71
6
71
4
71
EG008
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in this arm.
0
71
7
71
16
71
EG009
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in that arm.
0
324
34
324
64
324
EG010
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in this arm.
1
653
17
653
101
653
EG011
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
0
174
4
174
23
174
EG012
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
0
68
1
68
9
68
EG013
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
0
71
4
71
10
71
EG014
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
0
71
1
71
23
71
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0022 events2 affected61 at risk
EG0030 events0 affected58 at risk
EG0040 events0 affected341 at risk
EG0050 events0 affected36 at risk
EG0060 events0 affected37 at risk
EG0070 events0 affected71 at risk
EG0081 events1 affected71 at risk
EG0093 events2 affected324 at risk
EG0102 events2 affected653 at risk
EG0110 events0 affected174 at risk
EG0120 events0 affected68 at risk
EG0130 events0 affected71 at risk
EG0140 events0 affected71 at risk
BLOOD LOSS ANAEMIA
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ARTERIOSCLEROSIS CORONARY ARTERY
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
BASEDOW'S DISEASE
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CATARACT
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ANAL FISTULA
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ANAL PROLAPSE
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PYREXIA
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
HEPATIC CIRRHOSIS
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ABSCESS LIMB
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CYTOMEGALOVIRUS INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
DEVICE RELATED SEPSIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ENDOCARDITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ENTERITIS INFECTIOUS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
LARGE INTESTINE INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected61 at risk
EG003
LUNG ABSCESS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PAROTID ABSCESS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PHARYNGEAL ABSCESS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PNEUMONIA HAEMOPHILUS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PNEUMONIA MYCOPLASMAL
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
POST PROCEDURAL INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
RECTAL ABSCESS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SALMONELLOSIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
FOREARM FRACTURE
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SKELETAL INJURY
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
OSTEONECROSIS
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
COLORECTAL ADENOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PITUITARY TUMOUR BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
RENAL CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CEREBRAL MASS EFFECT
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ADJUSTMENT DISORDER
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
GENERALISED ANXIETY DISORDER
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
MAJOR DEPRESSION
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
CALCULUS URINARY
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected61 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
UTERINE PROLAPSE
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
RESPIRATORY DISTRESS
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ERYTHEMA NODOSUM
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PEMPHIGOID
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
ARTERIAL OCCLUSIVE DISEASE
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
PERIPHERAL ARTERY OCCLUSION
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected59 at risk
EG0010 events0 affected62 at risk
EG0023 events2 affected61 at risk
EG0031 events1 affected58 at risk
EG00412 events12 affected341 at risk
EG0050 events0 affected36 at risk
EG0061 events1 affected37 at risk
EG0071 events1 affected71 at risk
EG0081 events1 affected71 at risk
EG00921 events19 affected324 at risk
EG01021 events21 affected653 at risk
EG0115 events5 affected174 at risk
EG0121 events1 affected68 at risk
EG0132 events2 affected71 at risk
EG0146 events6 affected71 at risk
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0006 events5 affected59 at risk
EG0011 events1 affected62 at risk
EG0023 events3 affected61 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected62 at risk
EG0021 events1 affected61 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected61 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0005 events4 affected59 at risk
EG0015 events5 affected62 at risk
EG0025 events3 affected61 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected61 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected61 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0004 events3 affected59 at risk
EG0012 events2 affected62 at risk
EG0023 events3 affected61 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events2 affected62 at risk
EG0020 events0 affected61 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.
Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, > 7).
0.0460
P-value ≤ 0.05
Adjusted Risk Difference
8.4
2-Sided
90
1.5
15.3
Risk difference = (risankizumab - Placebo)
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, > 7).
0.0397
P-value ≤ 0.05.
Adjusted Risk Difference
8.7
2-Sided
90
1.7
15.6
Risk difference = (risankizumab - Placebo).
Superiority
Units
Counts
Participants
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG0006.2(3.6 to 8.9)
OG00120.3(17.2 to 23.4)
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
Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, > 7).
<0.0001
Type I error rate control.
Adjusted Risk Difference
14.0
2-Sided
95
10.0
18.0
Superiority
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG0003
OG00115
OG0028
OG0039
OG00461
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
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0028
P-value ≤ 0.01
Adjusted Risk Difference
18.7
2-Sided
90
8.4
29.0
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0968
P-value ≤ 0.1
Adjusted Risk Difference
8.4
2-Sided
90
0.1
16.7
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0512
P-value ≤ 0.1
Adjusted Risk Difference
10.5
2-Sided
90
1.6
19.3
Risk difference = (risankizumab - Placebo).
Superiority
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG00012
OG00126
OG00228
OG00331
OG004157
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
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0022
P-value ≤ 0.01
Adjusted Risk Difference
23.9
2-Sided
90
11.0
36.7
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0002
P-value ≤ 0.001
Adjusted Risk Difference
28.4
2-Sided
90
15.7
41.1
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
<0.0001
P-value ≤ 0.001
Adjusted Risk Difference
33.8
2-Sided
90
20.7
46.9
Risk difference = (risankizumab - Placebo).
Superiority
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG00015
OG00120
OG00228
OG00322
OG004148
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
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.1842
Adjusted Risk Difference
10.2
2-Sided
90
-2.4
22.9
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0041
P-value ≤ 0.01
Adjusted Risk Difference
23.2
2-Sided
90
9.9
36.4
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.1117
Adjusted Risk Difference
13.1
2-Sided
90
-0.4
26.6
Risk difference = (risankizumab - Placebo).
Superiority
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015
OG0023
OG0035
OG00422
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
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0192
P-value ≤ 0.05
Adjusted Risk Difference
8.3
2-Sided
90
2.5
14.1
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0706
P-value ≤ 0.1
Adjusted Risk Difference
4.8
2-Sided
90
0.4
9.1
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0170
P-value ≤ 0.05
Adjusted Risk Difference
8.7
2-Sided
90
2.7
14.6
Risk difference = (risankizumab - Placebo).
Superiority
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG0005
OG0016
OG0024
OG0033
OG00419
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
Chi-squared
P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.
0.7737
Superiority
OG000
OG002
Fisher Exact
P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.
0.7432
Superiority
OG000
OG003
Fisher Exact
P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.
0.7172
Superiority
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013
OG0022
OG0031
OG00410
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
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.0722
P-value ≤ 0.1
Adjusted Risk Difference
4.7
2-Sided
90
0.4
9.0
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.1480
Adjusted Risk Difference
3.1
2-Sided
90
-0.4
6.6
Risk difference = (risankizumab - Placebo).
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (<= 7, > 7).
0.3042
Adjusted Risk Difference
1.7
2-Sided
90
-1.0
4.5
Risk difference = (risankizumab - Placebo).
Superiority
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00050
OG00152
OG00256
OG00353
OG004286
Title
Denominators
Categories
Title
Measurements
OG000-7.4± 1.53
OG001-13.8± 1.50
OG002-15.6± 1.46
OG003-15.1± 1.51
OG004-17.1± 0.58
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
Mixed-effect model repeated measurement
0.0030
P-value ≤ 0.01
Least Squares (LS) Mean Difference
-6.4
Standard Error of the Mean
2.13
2-Sided
90
-9.94
-2.89
Superiority
OG000
OG002
Mixed-effect model repeated measurement
0.0001
P-value ≤ 0.001
Least Squares (LS) Mean Difference
-8.2
Standard Error of the Mean
2.11
2-Sided
90
-11.67
-4.71
Superiority
OG000
OG003
Mixed-effect model repeated measurement
0.0004
P-value ≤ 0.001
Least Squares (LS) Mean Difference
-7.7
Standard Error of the Mean
2.14
2-Sided
90
-11.27
-4.19
Superiority
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00051
OG00155
OG00259
OG00354
OG004305
Title
Denominators
Categories
Title
Measurements
OG00020.1± 4.67
OG00137.4± 4.56
OG00240.3± 4.38
OG00340.0± 4.55
OG00449.5± 1.86
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
Mixed-effect model repeated measurement
0.0081
P-value ≤ 0.01
Least Squares (LS) Mean Difference
17.3
Standard Error of the Mean
6.47
2-Sided
90
6.61
28
Superiority
OG000
OG002
Mixed-effect model repeated measurement
0.0017
P-value ≤ 0.01
Least Squares (LS) Mean Difference
20.3
Standard Error of the Mean
6.37
2-Sided
90
9.74
30.79
Superiority
OG000
OG003
Mixed-effect model repeated measurement
0.0024
P-value ≤ 0.01
Least Squares (LS) Mean Difference
19.9
Standard Error of the Mean
6.49
2-Sided
90
9.22
30.67
Superiority
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00051
OG00154
OG00259
OG00354
OG004298
Title
Denominators
Categories
Title
Measurements
OG0003.904± 0.8907
OG0015.112± 0.8751
OG0026.350± 0.8341
OG0036.296± 0.8675
OG0047.719± 0.3929
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
Mixed-effect model repeated measurement
0.3315
Least Squares (LS) Mean Difference
1.208
2-Sided
90
-0.8429
3.2596
Superiority
OG000
OG002
Mixed-effect model repeated measurement
0.0451
P-value ≤ 0.05
LS Mean of Difference
2.447
2-Sided
90
0.4415
4.4519
Superiority
OG000
OG003
Mixed-effect model repeated measurement
0.0543
P-value ≤ 0.1
LS Mean of Difference
2.392
2-Sided
90
0.3498
4.4352
Superiority
OG002
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00051
OG00154
OG00259
OG00354
OG004298
Title
Denominators
Categories
Title
Measurements
OG0003.094± 1.2533
OG0016.756± 1.2319
OG0027.284± 1.1739
OG0035.442± 1.2185
OG0047.777± 0.4777
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
Mixed-effect model repeated measurement
0.0367
P-value <= 0.1
LS Mean of Difference
3.662
2-Sided
90
0.7841
6.5402
P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.
Superiority
OG000
OG002
Mixed-effect model repeated measurement
0.0151
P-value <= 0.05
LS Mean of Difference
4.190
2-Sided
90
1.3656
7.0144
P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.
Superiority
OG000
OG003
Mixed-effect model repeated measurement
0.1795
LS Mean of Difference
2.348
2-Sided
90
-0.5322
5.2281
P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.
Superiority
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
OG003
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00051
OG00154
OG00259
OG00354
OG004298
Title
Denominators
Categories
Title
Measurements
OG0003.7± 1.37
OG0017.6± 1.35
OG0029.0± 1.29
OG0038.3± 1.33
OG00410.7± 0.54
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
Mixed-effect model repeated measurement
0.0422
P-value ≤ 0.05
Least Squares (LS) Mean Difference
3.9
Standard Error of the Mean
1.91
2-Sided
90
0.75
7.06
Superiority
OG000
OG002
Mixed-effect model repeated measurement
0.0049
P-value ≤ 0.01
Least Squares (LS) Mean Difference
5.3
Standard Error of the Mean
1.87
2-Sided
90
2.23
8.42
Superiority
OG000
OG003
Mixed-effect model repeated measurement
0.0156
P-value ≤ 0.05
Least Squares (LS) Mean Difference
4.6
Standard Error of the Mean
1.91
2-Sided
90
1.50
7.80
Superiority
OG004
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Units
Counts
Participants
OG00060
OG00161
OG00261
OG00358
OG004340
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0047
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
Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.
Fisher Exact
1
P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.
Superiority
Units
Counts
Participants
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00035.7(30.5 to 40.9)
OG00164.3(60.6 to 67.9)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
28.6
2-Sided
95
22.3
34.8
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.
Superiority
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00012.1(8.5 to 15.6)
OG00136.5(32.8 to 40.2)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
24.3
2-Sided
95
19.3
29.4
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
Units
Counts
Participants
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG0007.7(4.8 to 10.6)
OG00124.5(21.2 to 27.8)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
16.6
2-Sided
95
12.3
21.0
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG0003.4(1.4 to 5.4)
OG00110.6(8.2 to 13.0)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
7.2
2-Sided
95
4.2
10.2
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
Units
Counts
Participants
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00030.5(25.5 to 35.5)
OG00152.2(48.3 to 56.0)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
21.8
2-Sided
95
15.6
28.1
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00027.7(22.8 to 32.6)
OG00144.1(40.3 to 47.9)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
16.3
2-Sided
95
10.3
22.4
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00026.5(21.7 to 31.3)
OG00135.8(32.1 to 39.4)
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
0.0021
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
9.3
2-Sided
95
3.4
15.3
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
Units
Counts
Participants
OG000325
OG001650
Title
Denominators
Categories
Title
Measurements
OG0000.6(0.0 to 1.5)
OG0016.3(4.4 to 8.2)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
5.6
2-Sided
95
3.5
7.7
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
Participants
OG000308
OG001614
Title
Denominators
Categories
Title
Measurements
OG0003.3(2.12 to 4.50)
OG0017.9(7.03 to 8.69)
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
ANCOVA
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Least Squares (LS) Mean Difference
4.5
2-Sided
95
3.13
5.97
Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.
Superiority
Participants
OG000310
OG001619
Title
Denominators
Categories
Title
Measurements
OG00024.3(20.19 to 28.46)
OG00142.6(39.72 to 45.57)
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
ANCOVA
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Least Squares (LS) Mean Difference
18.3
2-Sided
95
13.38
23.25
Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG0005.5(3.1 to 8.0)
OG0010.8(0.1 to 1.4)
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
Chi-squared
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Risk Difference (RD)
-4.8
2-Sided
95
-7.3
-2.2
95% CI for treatment differences is based on normal approximation of the binomial proportions.
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00043.1(37.7 to 48.5)
OG00167.3(63.7 to 70.9)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
24.2
2-Sided
95
17.9
30.5
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).
Superiority
325
OG001650
Title
Denominators
Categories
Title
Measurements
OG00030.2(25.2 to 35.1)
OG00148.7(44.9 to 52.6)
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
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Adjusted Risk Difference
18.6
2-Sided
95
12.4
24.8
Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.
Superiority
288
OG001602
Title
Denominators
Categories
Title
Measurements
OG000-2.213(-2.8526 to -1.5726)
OG001-3.839(-4.2687 to -3.4099)
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
Mixed-Effect Model Repeated Measures
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Least Squares (LS) Mean Difference
-1.627
2-Sided
95
-2.3846
-0.8689
Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.
Superiority
288
OG001602
Title
Denominators
Categories
Title
Measurements
OG000-1.505(-1.7969 to -1.2122)
OG001-2.485(-2.6872 to -2.2831)
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
Mixed-Effect Model Repeated Measures
<0.0001
Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.
Least Squares (LS) Mean Difference
-0.981
2-Sided
95
-1.3285
-0.6326
Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.