Actively Recruiting
A Phase 2a Multicenter, Randomized Study of Targeted Therapies for Adults With Moderate to Severe Crohns Disease
Led by AbbVie · Updated on 2026-06-05
540
Participants Needed
255
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Crohns disease is a long-term condition causing severe inflammation in the digestive tract, mainly the bowels. It leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. Treatments exist but may not work the same for everyone or may lose effectiveness over time. This study is evaluating the effectiveness and side effects of several targeted therapies TaTs in adults with moderate to severe Crohns disease. About 540 adults will participate at around 300 sites worldwide to better understand these treatments. Participants will be randomly assigned to different treatment groups receiving various combinations or single therapies. These include Risankizumab, Trosunilimab, Lutikizumab, and ABBV-8736, delivered either by subcutaneous injection or intravenous infusion. Some groups receive monotherapy while others receive combination therapies. Treatment can last up to 72 weeks, with specific dosing schedules for each drug. The study includes a long-term extension phase for Risankizumab monotherapy. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, endoscopies, and monitoring for side effects. They will also complete questionnaires and keep a daily diary to track symptoms. The main outcomes measured include the percentage of participants achieving endoscopic remission at 12 weeks and the number experiencing adverse events over about 96 weeks. Secondary measures focus on clinical remission and response. This careful monitoring helps researchers understand how well the therapies work and their safety profiles.
CONDITIONS
Brief Title
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must weigh at least 40 kg at the start of the study.
- Confirmed diagnosis of Crohn's disease for at least 3 months before starting.
- Crohn's Disease Activity Index (CDAI) score of 220 or higher at baseline.
- Evidence of mucosal inflammation with specific endoscopic scores based on disease location.
- Participants must have shown intolerance or inadequate response to conventional therapies or targeted therapies including biologics and small molecules.
You will not qualify if you...
- Participants intolerant to p19 inhibitors, including risankizumab, are excluded.
- Participants who received investigational targeted therapies within 30 days or 5 half-lives before baseline are excluded, unless drug levels are undetectable.
- Participants with current ulcerative colitis or indeterminate colitis are excluded.
- Participants with certain Crohn's disease complications such as current ostomy, ileoanal pouch, short gut syndrome, or recent bowel surgery within 3 months are excluded.
- Participants with surgical bowel resection within 3 months prior to baseline are excluded.
Research Team
A
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