Ulcerative Colitis (UC)
Conditions
Keywords
ABBV-066, BI 655066
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.
Interventions
DRUGrisankizumab IV
risankizumab intravenous (IV) infusion
placebo for risankizumab
DRUGrisankizumab SC
risankizumab subcutaneous (SC) injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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. |
| Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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. |
| Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. 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. |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Week 12 | Endoscopic remission was defined as endoscopy subscore of 0. |
| Sub-Study 1: Percentage of Participants With Hospitalization | Through Week 12 | Participants with an event that results in admission to the hospital. |
| Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 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. |
| Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | Baseline Through Week 12 | 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. |
| Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline Through Week 12 | 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. |
| Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | Baseline Through Week 12 | 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. |
| Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | Baseline through Week 12 | 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. |
| Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline Through Week 12 | 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 1. = a little bit 2. = somewhat 3. = quite a bit 4. = 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. |
| Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | Through Week 12 | Participants who underwent surgery related to UC. |
| Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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). |
| Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week | Baseline to Week 12 | Change in number of fecal incontinence episodes per week. |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | 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). |
| Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | 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). |
| Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) | Week 12 | 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. |
| Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission | Week 12 | Endoscopic remission per endoscopy subscore. Endoscopic Remission: endoscopic subscore = 0. |
| Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4 | 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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. 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. |
| Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency | Week 12 | Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day. |
| Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain | Week 12 | Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day. |
| Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 | 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. |
| Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline to Week 12 | 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 1. = a little bit 2. = somewhat 3. = quite a bit 4. = 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. |
| Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | Baseline to Week 12 | 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. |
| Sub-Study 2: Occurrence of UC-related Hospitalizations | Baseline Through Week 12 | Participants with an UC-related event that results in admission to the hospital. |
| Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements | Week 12 | Percentage of participants who reported no nocturnal bowel movements. |
| Sub-Study 2: Percentage of Participants Achieving No Tenesmus | Week 12 | Percentage of participants who reported no tenesmus. |
| Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms | Baseline to Week 12 | Change from baseline in number of days per week with sleep interrupted due to UC symptoms. |
| 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 | Week 12 | 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. |
Countries
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, United States
Participant flow
Pre-assignment details
This study was comprised of 2 SubStudies, each had 2 Periods.
Participants by arm
| Arm | Count |
|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. | 60 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion. | 61 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion. | 61 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion. | 58 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV Participants receive risankizumab 1800mg administered by intravenous (IV) infusion. | 340 |
| Substudy 2, Induction Period 1: Double-blind Placebo IV Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. | 325 |
| Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion. | 650 |
| Total | 1,555 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Substudy 1 Period 1 | Adverse Event | 5 | 2 | 2 | 0 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 1 | Enrolled but not Treated | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 1 | Lack of Efficacy | 1 | 1 | 1 | 0 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 1 | Other | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 1 | WITHDREW CONSENT | 1 | 2 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | COVID-19 LOGISTICAL RESTRICTIONS | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | Enrolled but not Treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 5 | 5 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 1 Period 2 | WITHDREW CONSENT | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 2 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | COVID-19 INFECTION | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | COVID-19 LOGISTICAL RESTRICTIONS | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | Enrolled but not Treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 1 | WITHDREW CONSENT | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 4 | 0 | 0 | 0 | 0 |
| Substudy 2 Period 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 |
| Substudy 2 Period 2 | Enrolled but not Treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Substudy 2 Period 2 | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 3 | 4 |
| Substudy 2 Period 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Substudy 2 Period 2 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Substudy 2 Period 2 | WITHDREW CONSENT | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Total | Substudy 1, Induction Period 1: Double-blind Placebo IV | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV | Substudy 2, Induction Period 1: Double-blind Placebo IV |
|---|---|---|---|---|---|---|---|---|
| Adapted Mayo Score Substudy 1 - ITT1A Population | 7.011 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.1288 | 7.150 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.3908 | 7.024 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.224 | 7.012 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.1645 | 6.929 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.224 | — | — | — |
| Adapted Mayo Score Substudy 1 - ITT1B Population | — | — | 7.179 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.2279 | — | — | 7.179 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.2279 | — | — |
| Adapted Mayo Score Substudy 2 - ITT2 Population | — | — | 7.063 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.238 | — | — | — | 7.068 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.2173 | 7.052 Adapted Mayo Score 0 - 9 STANDARD_DEVIATION 1.28 |
| Age, Continuous Substudy 1 | 41.8 years STANDARD_DEVIATION 13.8 | 40.9 years STANDARD_DEVIATION 13.73 | 42.5 years STANDARD_DEVIATION 14.12 | 44.4 years STANDARD_DEVIATION 14.09 | 43.0 years STANDARD_DEVIATION 14.9 | 40.4 years STANDARD_DEVIATION 14.17 | — | — |
| Age, Continuous Substudy 2 | — | — | 42.1 years STANDARD_DEVIATION 13.75 | — | — | — | 41.8 years STANDARD_DEVIATION 13.47 | 42.8 years STANDARD_DEVIATION 14.3 |
| Age, Customized Age Group 18 - <40 | 30 Participants | 33 Participants | 750 Participants | 25 Participants | 27 Participants | 175 Participants | 313 Participants | 147 Participants |
| Age, Customized Age Group 40 - <65 | 27 Participants | 20 Participants | 698 Participants | 29 Participants | 27 Participants | 143 Participants | 299 Participants | 153 Participants |
| Age, Customized Age Group ≥65 | 4 Participants | 5 Participants | 107 Participants | 6 Participants | 7 Participants | 22 Participants | 38 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 97 Participants | 3 Participants | 2 Participants | 21 Participants | 44 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 57 Participants | 1458 Participants | 57 Participants | 59 Participants | 319 Participants | 606 Participants | 305 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 11 Participants | 365 Participants | 14 Participants | 11 Participants | 47 Participants | 171 Participants | 96 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 28 Participants | 2 Participants | 1 Participants | 3 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 45 Participants | 1152 Participants | 44 Participants | 49 Participants | 290 Participants | 461 Participants | 218 Participants |
| Sex: Female, Male Female | 26 Participants | 27 Participants | 632 Participants | 24 Participants | 21 Participants | 145 Participants | 265 Participants | 124 Participants |
| Sex: Female, Male Male | 35 Participants | 31 Participants | 923 Participants | 36 Participants | 40 Participants | 195 Participants | 385 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 62 | 0 / 61 | 0 / 58 | 0 / 341 | 0 / 36 | 0 / 37 | 0 / 71 | 0 / 71 | 0 / 324 | 1 / 653 | 0 / 174 | 0 / 68 | 0 / 71 | 0 / 71 |
| other Total, other adverse events | 14 / 59 | 13 / 62 | 12 / 61 | 12 / 58 | 76 / 341 | 11 / 36 | 6 / 37 | 4 / 71 | 16 / 71 | 64 / 324 | 101 / 653 | 23 / 174 | 9 / 68 | 10 / 71 | 23 / 71 |
| serious Total, serious adverse events | 6 / 59 | 6 / 62 | 4 / 61 | 5 / 58 | 25 / 341 | 3 / 36 | 1 / 37 | 6 / 71 | 7 / 71 | 34 / 324 | 17 / 653 | 4 / 174 | 1 / 68 | 4 / 71 | 1 / 71 |
Outcome results
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 1 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 7 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 6 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 6 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 42 Participants |
p-value: 0.032490% CI: [2.2, 17]Cochran-Mantel-Haenszel
p-value: 0.04690% CI: [1.5, 15.3]Cochran-Mantel-Haenszel
p-value: 0.039790% CI: [1.7, 15.6]Cochran-Mantel-Haenszel
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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.
Time frame: Week 12
Population: ITT2 population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 6.2 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | 20.3 percentage of participants |
p-value: <0.000195% CI: [10, 18]Cochran-Mantel-Haenszel
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.
Time frame: Baseline through Week 12
Population: Includes ITT1A and ITT1B participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | 3.094 unites on a scale | Standard Error 1.2533 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | 6.756 unites on a scale | Standard Error 1.2319 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | 7.284 unites on a scale | Standard Error 1.1739 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | 5.442 unites on a scale | Standard Error 1.2185 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | 7.777 unites on a scale | Standard Error 0.4777 |
p-value: 0.179590% CI: [-0.5322, 5.2281]Mixed-effect model repeated measurement
p-value: 0.036790% CI: [0.7841, 6.5402]Mixed-effect model repeated measurement
p-value: 0.015190% CI: [1.3656, 7.0144]Mixed-effect model repeated measurement
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.
Time frame: Baseline Through Week 12
Population: Includes ITT1A and ITT1B participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | 3.904 units on a scale | Standard Error 0.8907 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | 5.112 units on a scale | Standard Error 0.8751 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | 6.350 units on a scale | Standard Error 0.8341 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | 6.296 units on a scale | Standard Error 0.8675 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | 7.719 units on a scale | Standard Error 0.3929 |
p-value: 0.331590% CI: [-0.8429, 3.2596]Mixed-effect model repeated measurement
p-value: 0.045190% CI: [0.4415, 4.4519]Mixed-effect model repeated measurement
p-value: 0.054390% CI: [0.3498, 4.4352]Mixed-effect model repeated measurement
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 1. = a little bit 2. = somewhat 3. = quite a bit 4. = 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.
Time frame: Baseline Through Week 12
Population: Includes ITT1A and ITT1B participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3.7 units on a scale | Standard Error 1.37 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 7.6 units on a scale | Standard Error 1.35 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 9.0 units on a scale | Standard Error 1.29 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 8.3 units on a scale | Standard Error 1.33 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 10.7 units on a scale | Standard Error 0.54 |
p-value: 0.042290% CI: [0.75, 7.06]Mixed-effect model repeated measurement
p-value: 0.004990% CI: [2.23, 8.42]Mixed-effect model repeated measurement
p-value: 0.015690% CI: [1.5, 7.8]Mixed-effect model repeated measurement
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.
Time frame: Baseline Through Week 12
Population: Includes ITT1A and ITT1B participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | 20.1 units on a scale | Standard Error 4.67 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | 37.4 units on a scale | Standard Error 4.56 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | 40.3 units on a scale | Standard Error 4.38 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | 40.0 units on a scale | Standard Error 4.55 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | 49.5 units on a scale | Standard Error 1.86 |
p-value: 0.008190% CI: [6.61, 28]Mixed-effect model repeated measurement
p-value: 0.001790% CI: [9.74, 30.79]Mixed-effect model repeated measurement
p-value: 0.002490% CI: [9.22, 30.67]Mixed-effect model repeated measurement
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.
Time frame: Baseline Through Week 12
Population: Includes ITT1A and ITT1B participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | -7.4 units on a scale | Standard Error 1.53 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | -13.8 units on a scale | Standard Error 1.5 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | -15.6 units on a scale | Standard Error 1.46 |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | -15.1 units on a scale | Standard Error 1.51 |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | -17.1 units on a scale | Standard Error 0.58 |
p-value: 0.00390% CI: [-9.94, -2.89]Mixed-effect model repeated measurement
p-value: 0.000190% CI: [-11.67, -4.71]Mixed-effect model repeated measurement
p-value: 0.000490% CI: [-11.27, -4.19]Mixed-effect model repeated measurement
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.
Time frame: Week 12
Population: No data was collected.
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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.
Time frame: Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 12 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 26 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 28 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 31 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 157 Participants |
p-value: 0.002290% CI: [11, 36.7]Cochran-Mantel-Haenszel
p-value: 0.000290% CI: [15.7, 41.1]Cochran-Mantel-Haenszel
p-value: <0.000190% CI: [20.7, 46.9]Cochran-Mantel-Haenszel
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. 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.
Time frame: Week 4
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 15 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 20 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 28 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 22 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | 148 Participants |
p-value: 0.184290% CI: [-2.4, 22.9]Cochran-Mantel-Haenszel
p-value: 0.004190% CI: [9.9, 36.4]Cochran-Mantel-Haenszel
p-value: 0.111790% CI: [-0.4, 26.6]Cochran-Mantel-Haenszel
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).
Time frame: Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | 3 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | 15 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | 8 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | 9 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | 61 Participants |
p-value: 0.002890% CI: [8.4, 29]Cochran-Mantel-Haenszel
p-value: 0.096890% CI: [0.1, 16.7]Cochran-Mantel-Haenszel
p-value: 0.051290% CI: [1.6, 19.3]Cochran-Mantel-Haenszel
Secondary
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission was defined as endoscopy subscore of 0.
Time frame: Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | 0 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | 5 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | 3 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | 5 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | 22 Participants |
p-value: 0.019290% CI: [2.5, 14.1]Cochran-Mantel-Haenszel
p-value: 0.070690% CI: [0.4, 9.1]Cochran-Mantel-Haenszel
p-value: 0.01790% CI: [2.7, 14.6]Cochran-Mantel-Haenszel
Secondary
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)
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.
Time frame: Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 0 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 3 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 2 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 1 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | 10 Participants |
p-value: 0.072290% CI: [0.4, 9]Cochran-Mantel-Haenszel
p-value: 0.14890% CI: [-0.4, 6.6]Cochran-Mantel-Haenszel
p-value: 0.304290% CI: [-1, 4.5]Cochran-Mantel-Haenszel
Secondary
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries
Participants who underwent surgery related to UC.
Time frame: Through Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | 0 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | 1 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | 0 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | 0 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | 7 Participants |
Comparison: Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.p-value: 1Fisher Exact
Secondary
Sub-Study 1: Percentage of Participants With Hospitalization
Participants with an event that results in admission to the hospital.
Time frame: Through Week 12
Population: Includes ITT1A and ITT1B populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 1: Percentage of Participants With Hospitalization | 5 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 1: Percentage of Participants With Hospitalization | 6 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | Sub-Study 1: Percentage of Participants With Hospitalization | 4 Participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants With Hospitalization | 3 Participants |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | Sub-Study 1: Percentage of Participants With Hospitalization | 19 Participants |
p-value: 0.7737Chi-squared
p-value: 0.7432Fisher Exact
p-value: 0.7172Fisher Exact
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 1. = a little bit 2. = somewhat 3. = quite a bit 4. = 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.
Time frame: Baseline to Week 12
Population: Includes ITT2 participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3.3 units on a scale |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 7.9 units on a scale |
p-value: <0.000195% CI: [3.13, 5.97]ANCOVA
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.
Time frame: Baseline to Week 12
Population: Includes ITT2 participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | 24.3 units on a scale |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | 42.6 units on a scale |
p-value: <0.000195% CI: [13.38, 23.25]ANCOVA
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.
Time frame: Baseline to Week 12
Population: Includes ITT2 participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms | -1.505 days |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms | -2.485 days |
p-value: <0.000195% CI: [-1.3285, -0.6326]Mixed-Effect Model Repeated Measures
Secondary
Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week
Change in number of fecal incontinence episodes per week.
Time frame: Baseline to Week 12
Population: Includes ITT2 participants with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week | -2.213 Fecal Incontinence Episodes/ week |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week | -3.839 Fecal Incontinence Episodes/ week |
p-value: <0.000195% CI: [-2.3846, -0.8689]Mixed-Effect Model Repeated Measures
Secondary
Sub-Study 2: Occurrence of UC-related Hospitalizations
Participants with an UC-related event that results in admission to the hospital.
Time frame: Baseline Through Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Occurrence of UC-related Hospitalizations | 5.5 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Occurrence of UC-related Hospitalizations | 0.8 percentage of participants |
p-value: <0.000195% CI: [-7.3, -2.2]Chi-squared
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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).
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 35.7 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | 64.3 percentage of participants |
p-value: <0.000195% CI: [22.3, 34.8]Cochran-Mantel-Haenszel
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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. 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.
Time frame: Week 4
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4 | 30.5 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4 | 52.2 percentage of participants |
p-value: <0.000195% CI: [15.6, 28.1]Cochran-Mantel-Haenszel
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).
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement | 12.1 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement | 36.5 percentage of participants |
p-value: <0.000195% CI: [19.3, 29.4]Cochran-Mantel-Haenszel
Secondary
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission per endoscopy subscore. Endoscopic Remission: endoscopic subscore = 0.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission | 3.4 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission | 10.6 percentage of participants |
p-value: <0.000195% CI: [4.2, 10.2]Cochran-Mantel-Haenszel
Secondary
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)
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.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) | 7.7 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) | 24.5 percentage of participants |
p-value: <0.000195% CI: [12.3, 21]Cochran-Mantel-Haenszel
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.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 | 0.6 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 | 6.3 percentage of participants |
p-value: <0.000195% CI: [3.5, 7.7]Cochran-Mantel-Haenszel
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.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain | 26.5 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain | 35.8 percentage of participants |
p-value: 0.002195% CI: [3.4, 15.3]Cochran-Mantel-Haenszel
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.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency | 27.7 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency | 44.1 percentage of participants |
p-value: <0.000195% CI: [10.3, 22.4]Cochran-Mantel-Haenszel
Secondary
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Percentage of participants who reported no nocturnal bowel movements.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements | 43.1 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements | 67.3 percentage of participants |
p-value: <0.000195% CI: [17.9, 30.5]Cochran-Mantel-Haenszel
Secondary
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Percentage of participants who reported no tenesmus.
Time frame: Week 12
Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy 1, Induction Period 1: Double-blind Placebo IV | Sub-Study 2: Percentage of Participants Achieving No Tenesmus | 30.2 percentage of participants |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | Sub-Study 2: Percentage of Participants Achieving No Tenesmus | 48.7 percentage of participants |
p-value: <0.000195% CI: [12.4, 24.8]Cochran-Mantel-Haenszel