The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
931
Placebo for risankizumab administered by intravenous infusion
Risankizumab administered by intravenous infusion
Risankizumab administered by subcutaneous (SC) injection
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Time frame: Week 12
US Specific: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time frame: Week 12
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time frame: Week 12
Global Outside of US: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time frame: Week 12
US Specific: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time frame: Week 12
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Phoenix VA Health Care System /ID# 162267
Phoenix, Arizona, United States
HonorHealth Research Institute - Shea /ID# 161783
Scottsdale, Arizona, United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211883
Tempe, Arizona, United States
University of Arizona /ID# 158469
Tucson, Arizona, United States
Atria Clinical Research /ID# 164740
Little Rock, Arkansas, United States
Newport Huntington Medica /ID# 213033
Huntington Beach, California, United States
United Medical Doctors /ID# 207040
Los Alamitos, California, United States
TLC Clinical Research Inc /ID# 212503
Los Angeles, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162656
Los Angeles, California, United States
United Medical Doctors - Murrieta /ID# 158424
Murrieta, California, United States
...and 465 more locations
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time frame: Week 4
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time frame: Week 12
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 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. 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: Week 12
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Time frame: Week 4
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline. Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Time frame: Week 12
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Stool Frequency (SF) remission is defined as an average daily SF \<= 2.8 and not worse than baseline.
Time frame: Week 12
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score \<= 1 and not worse than baseline.
Time frame: Week 12
US Specific: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time frame: Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time frame: Week 4
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time frame: Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time frame: Week 12
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time frame: Week 12
US Specific: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Time frame: Week 12
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time frame: Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Time frame: Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time frame: Week 4
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time frame: Week 4
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time frame: Week 12
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 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. 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: Week 12
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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: Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Time frame: Week 12
Global Outside of US: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time frame: Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time frame: Week 4
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time frame: Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time frame: Week 12
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time frame: Week 12
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Time frame: Week 12
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time frame: Week 12
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Week 12
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Time frame: Week 12