RVT-3101 for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

Eligibility Criteria

This trial is for adults with moderate to severe active Crohn's Disease who haven't had enough relief from at least one standard or advanced treatment. They should have specific symptoms and test results confirming their condition but can't join if they've had recent bowel surgery, short gut syndrome, or have an ostomy or ileoanal pouch.

Inclusion Criteria

I have been diagnosed with a type of colitis or active diverticular disease.

My Crohn's disease is moderate to severe, confirmed by specific tests.

I often have very soft or liquid stools and/or stomach pain.

+1 more

Exclusion Criteria

I had surgery on my intestines within the last 6 months.

I have short gut syndrome.

I have an ostomy or ileoanal pouch.

Participant Groups

The study tests RVT-3101's safety and effectiveness in treating Crohn's Disease. Participants are randomly assigned to receive either RVT-3101 or a placebo without knowing which one, and the outcomes will be monitored over time.

2Treatment groups

Experimental Treatment

Group I: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance doseExperimental Treatment1 Intervention

Group II: Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance doseExperimental Treatment1 Intervention