Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

In plain English

What this trial is testing

This study is testing Risankizumab (a drug), Trosunilimab (a drug) and ABBV-701 (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease and Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 75
• Any sex

Some of the main requirements, copied from the record:

• CD specific:
• Crohn's Disease Activity Index (CDAI) score of ≥ 220
• Confirmed diagnosis of CD at least 90 days prior to Baseline
• Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
• Demonstrated failure of 1 or more therapy for CD
• UC specific:

Plus 3 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 2000 participants are expected to take part.
• The study has 22 groups.
• Start date: 2026-07-31.
• Main results expected around 2031-10 (estimate from the record).
• 64 study sites listed (64 marked recruiting) in Canada, Israel, Taiwan and United States.

Groups in this study

• Substudy 1: UC Arm 1 Risankizumab monotherapy (listed as: experimental group)
• Substudy 1: CD Arm 1 Risankizumab monotherapy (listed as: experimental group)
• Substudy 1: UC Arm 2 Trosunilimab monotherapy (listed as: experimental group)
• Substudy 1: CD Arm 2 Trosunilimab monotherapy (listed as: experimental group)
• Substudy 1: UC Arm 3 Trosunilimab monotherapy (listed as: experimental group)
• Substudy 1: CD Arm 3 Trosunilimab monotherapy (listed as: experimental group)

Main thing being measured

• Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission (At Week 28)
• Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission (At Week 28)
• Number of Participants with Adverse Events (AEs) (Up to 98 Weeks)

In the researchers’ words

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,…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.