NCT06548542

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein. 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, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Risankizumab	Subcutaneous Injection
DRUG	Lutikizumab	Subcutaneous Injection
DRUG	Trosunilimab	Intravenous Infusion
DRUG	Risankizumab	Intravenous Infusion
DRUG	Trosunilimab	Subcutaneous Injection
DRUG	ABBV-8736	Intravenous Infusion

Timeline

• Start date: 2024-09-04
• Primary completion: 2027-12-01
• Completion: 2028-08-01
• First posted: 2024-08-12
• Last updated: 2026-04-01

Locations

254 sites across 33 countries: United States, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study