Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,000
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Digestive Health Specialists /ID# 280827
Dothan, Alabama, United States
RECRUITINGElite Clinical Studies /ID# 280477
Phoenix, Arizona, United States
RECRUITINGGi Alliance - Arizona Digestive Health - Sun City /ID# 284084
Sun City, Arizona, United States
RECRUITINGClinnova Research /ID# 280509
Anaheim, California, United States
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Time frame: At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 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: At Week 28
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time frame: Up to 98 Weeks
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Time frame: At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
The Simple Endoscopic Score for Crohn's Disease (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, and/or endoscopic remission, as scored by central reader.
Time frame: At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
The Simple Endoscopic Score for Crohn's Disease (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, and/or endoscopic remission, as scored by central reader.
Time frame: At Week 28
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
Time frame: At Week 12
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
Time frame: At Week 28
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
Time frame: At Week 12
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
Time frame: At Week 28
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS)
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore \<= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \[spontaneous bleeding, ulceration\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Time frame: At Week 12
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore \<= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \[spontaneous bleeding, ulceration\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Time frame: At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 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: At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies 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: At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies 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: At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
Clinical response per mMS is defined as decrease from baseline \>=2 points and \>=30%, PLUS a decrease in RBS \>= 1 or an absolute RBS \<=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \[spontaneous bleeding, ulceration\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Time frame: At Week 12
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
Clinical response per mMS is defined as decrease from baseline \>=2 points and \>=30%, PLUS a decrease in RBS \>= 1 or an absolute RBS \<=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \[spontaneous bleeding, ulceration\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Time frame: At Week 28
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Southern California Res. Ctr /ID# 280476
Coronado, California, United States
RECRUITINGGastro Care Institute /ID# 281071
Lancaster, California, United States
RECRUITINGUnited Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, California, United States
RECRUITINGInland Empire Liver Foundation - Rialto /ID# 280775
Rialto, California, United States
RECRUITINGPeak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
Colorado Springs, Colorado, United States
RECRUITINGSynergy Healthcare - Bradenton - 17th Avenue West /ID# 284157
Bradenton, Florida, United States
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