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

In plain English

What this trial is testing

This study is testing Risankizumab (a drug), Lutikizumab (a drug), Trosunilimab (a drug) and Risankizumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

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:

• Participants' body weight must be >= 40 kg at Baseline.
• Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
• CDAI >= 220 at Baseline.
• Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are…
• Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.

There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 590 participants are expected to take part.
• The study has 8 groups.
• Start date: 2024-09-04.
• Main results expected around 2030-01 (estimate from the record).
• 255 study sites listed (230 marked recruiting) in Austria, Belgium, Bulgaria, Canada and Croatia and 28 more countries.

Groups in this study

• Monotherapy: Risankizumab (listed as: experimental group)
• Combination Therapy: Risankizumab and Trosunilimab (listed as: experimental group)
• Monotherapy: Trosunilimab (listed as: experimental group)
• Combination Therapy: Risankizumab and Lutikizumab (listed as: experimental group)
• Monotherapy: Lutikizumab (listed as: experimental group)
• Monotherapy: ABBV-8736 - OUS Only (listed as: experimental group)

Main thing being measured

• Percentage of Participants who Achieve Endoscopic Remission (Week 12)
• Number of Participants with Adverse Events (AEs) (Up to approximately 96 weeks)

In the researchers’ words

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 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.