NotablePrimary endpoints: details revised at 1 of 3 entries
Trial sites expanded: 43 → 47 locations
Eligibility criteria expanded, about 15 words
Secondary endpoints: details revised at 11 of 14 entries
MinorTrial sites expanded: 39 → 42 locations
Trial sites expanded: 36 → 39 locations
Trial sites expanded: 27 → 30 locations
v8
MinorStudy sites: 27 to 30v7
MinorStudy sites: 26 to 27v6
MinorStudy sites: 24 to 26v5
MinorStudy sites: 22 to 24v4
NotableRecruitment opened
Trial sites reduced: 30 → 21 locations
v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 30 to 21
Start date changed from estimate of Jul 24, 2026 to Jul 31, 2026
v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.