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

Starting soon · Phase 2

Conditions studied: Crohn's Disease, Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT07697456
Run by: AbbVie
People needed: 2000
Starts: 2026-07-24
Expected to finish: 2031-10-01
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Confirmed diagnosis of UC at least 90 days prior to Baseline
Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
Demonstrated failure of 1 or more therapy for UC

You may not qualify if…

Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
Participants with surgical bowel resection within the past 3 months prior to Baseline
CD specific:
Participants with >3 prior bowel resections
Participants with previous small bowel resection(s) of combined length >100 cm
UC specific:
Participants with prior colectomy (total or subtotal)
Participants with extent of disease limited to < 10 cm of rectum

Where it is running

Auzmer Research /ID# 280786 — Lakeland, Florida, United States
Gastro Health - Miami /ID# 282001 — Miami, Florida, United States
Portland Gastroenterology Center - Portland - Congress Street /ID# 281970 — Portland, Maine, United States
Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865 — Hackensack, New Jersey, United States
Queens Village Primary Medical Center /ID# 281857 — New York, New York, United States
Digestive Disease Consultants - Brunswick /ID# 283935 — Brunswick, Ohio, United States
Skyline Gastroenterology of West Tennessee /ID# 284146 — Jackson, Tennessee, United States
Texas Digestive Disease Consultants /ID# 284159 — Austin, Texas, United States
Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947 — San Marcos, Texas, United States
Macquarie Hospital /ID# 281739 — Macquarie University, New South Wales, Australia
John Hunter Hospital /ID# 282537 — Newcastle, New South Wales, Australia
Mater Hospital Brisbane /ID# 281738 — South Brisbane, Queensland, Australia
Gold Coast Hospital /ID# 282434 — Southport, Queensland, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 281711 — Clayton, Victoria, Australia
Universitair Ziekenhuis Antwerpen /ID# 282218 — Edegem, Antwerpen, Belgium
Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632 — Lodelinsart, Hainaut, Belgium
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312 — Yvoir, Namur, Belgium
AZ-Delta. /ID# 281031 — Roeselare, West-Vlaanderen, Belgium
CHU de Liege /ID# 281182 — Liège, Belgium
Universitaetsklinikum Tuebingen /ID# 282958 — Tübingen, Baden-Wurttemberg, Germany
Iwate Medical University Hospital /ID# 282387 — Shiwa-gun, Iwate, Japan
Takagi Clinic - Sendai /ID# 281805 — Sendai, Miyagi, Japan
University Medical Centre Maribor /ID# 281175 — Maribor, Slovenia
Lenasia Clinical Trial Centre - Johannesburg /ID# 281415 — Johannesburg, Gauteng, South Africa
Chris Hani Baragwanath Hospital /ID# 284122 — Johannesburg, Gauteng, South Africa

Full record on ClinicalTrials.gov

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