RVT-3101 for Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RVT-3101 for individuals with moderate to severe Crohn's disease. The goal is to determine if this treatment safely and effectively reduces symptoms like frequent diarrhea and abdominal pain. Participants will receive one of two different dosing schedules to identify the best approach. Suitable candidates have not responded well to at least one other treatment, such as corticosteroids. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that RVT-3101 is likely to be safe for humans?
Research has shown that RVT-3101 is well tolerated by people with inflammatory bowel disease. Studies found it generally safe across all doses and patient groups, with most experiencing no serious side effects. While reassuring, individual reactions to treatment can vary. Ongoing research aims to better understand the safety and effectiveness of RVT-3101 for treating Crohn's disease.12345
Why do researchers think this study treatment might be promising for Crohn's disease?
Researchers are excited about RVT-3101 for Crohn's Disease because it offers a novel approach compared to current treatments, which often include medications like corticosteroids, immunosuppressants, and biologics. Unlike these standard treatments, RVT-3101 targets specific pathways involved in inflammation, potentially offering a more precise mechanism of action. This targeted approach could lead to improved efficacy and fewer side effects by honing in on the disease's underlying causes. Additionally, RVT-3101 might provide a new option for patients who don't respond well to existing therapies, offering hope for better disease management.
What evidence suggests that RVT-3101 might be an effective treatment for Crohn's disease?
Studies have shown promising results for RVT-3101 in treating Crohn's disease. In an earlier study, 36% of patients experienced symptom relief by week 56, up from 29% at week 14. Additionally, 50% of patients showed improved gut health, as observed through a camera, by week 56, compared to 36% at week 14. These findings suggest that RVT-3101 might help reduce symptoms and improve gut health in people with moderate to severe Crohn's disease. Participants in this trial will receive different induction doses of RVT-3101, followed by a maintenance dose, to further evaluate its effectiveness.12367
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive RVT-3101 induction dose to evaluate initial safety and efficacy
Maintenance
Participants continue with RVT-3101 maintenance dose to assess long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RVT-3101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University