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Monoclonal Antibodies

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
No Placebo-Only Group

Summary

This trial is testing a new medication called RVT-3101 in adults with moderate to severe Crohn's disease to see if it is safe and effective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the specific side effects of RVT-3101 aren't listed here, similar medications often cause immune system changes, infections, infusion reactions, liver issues, nausea, headaches, and fatigue.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants achieving clinical remission by CDAI
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,097,024 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,970 Total Patients Enrolled
~9 spots leftby Dec 2025
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