← Back to Search

Other

RVT-3101 for Crohn's Disease

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 64
Awards & highlights

Summary

This trial will test how safe and effective a new medicine is for adults with Crohn's disease.

Who is the study for?
Adults with moderate to severe active Crohn's Disease who haven't had enough relief from at least one standard treatment can join. They should have frequent soft or liquid stools, abdominal pain, and their condition confirmed by specific medical scores. People with an ostomy, short gut syndrome, or recent bowel surgery (~6 months) cannot participate.Check my eligibility
What is being tested?
The trial is testing RVT-3101's safety and effectiveness for treating Crohn's Disease. Participants are randomly assigned to receive either RVT-3101 or a placebo without knowing which one they're getting (double-blind). The study includes both initial treatment (induction) and ongoing treatment (maintenance) phases.See study design
What are the potential side effects?
Potential side effects of RVT-3101 aren't specified here but generally could include typical drug reactions like nausea, headaches, allergic reactions, or other symptoms depending on how the body responds to new treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving clinical remission by CDAI
Secondary outcome measures
Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation
Percentage of Participants with Anti-drug antibodies (ADA)
Percentage of Participants with Neutralizing Antibodies (NAb)
+7 more

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease include anti-TNF agents like infliximab, adalimumab, and certolizumab pegol, which work by neutralizing tumor necrosis factor-alpha (TNF-alpha), a cytokine involved in systemic inflammation. Another emerging treatment, similar to RVT-3101, is the Anti-TL1A Monoclonal Antibody, which targets TL1A, a cytokine that promotes inflammation and fibrosis in the gut. These treatments are crucial for Crohn's Disease patients as they help reduce inflammation, induce and maintain remission, and prevent complications, thereby improving quality of life and reducing the need for surgical interventions.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,615 Total Patients Enrolled
Telavant, Inc.Lead Sponsor
5 Previous Clinical Trials
404 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,286 Total Patients Enrolled

Media Library

RVT-3101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05910528 — Phase 2
Crohn's Disease Research Study Groups: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose, Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose
Crohn's Disease Clinical Trial 2023: RVT-3101 Highlights & Side Effects. Trial Name: NCT05910528 — Phase 2
RVT-3101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910528 — Phase 2
~10 spots leftby Jul 2025