RVT-3101 for Crohn's Disease

Recruiting at 39 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Short gut syndrome, Ostomy, Bowel resection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

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.

How does the drug RVT-3101 differ from other drugs for Crohn's disease?

RVT-3101 is unique because it may offer a new mechanism of action compared to existing treatments, which often focus on anti-inflammatory effects or immune system suppression. While traditional treatments like immunomodulatory drugs and anti-tumor necrosis factor-alpha antibodies aim to delay relapses, RVT-3101 could provide a novel approach, potentially improving outcomes for patients who do not respond well to current options. ^{1 2 3 4 5}

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive RVT-3101 induction dose to evaluate initial safety and efficacy

14 weeks

Maintenance

Participants continue with RVT-3101 maintenance dose to assess long-term safety and efficacy

50 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RVT-3101

Trial Overview 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.

Participant Groups

Group I: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose Experimental Treatment 1 Intervention

Group II: Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

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

References

1. England pubmed.ncbi.nlm.nih.gov

Review article: maintenance treatment of Crohn's disease. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Results of combined medical and surgical treatment of recto-vaginal fistula in Crohn's disease. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Early surgery in Crohn's disease a benefit in selected cases. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical features and natural history of Crohn's disease. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Plateletcrit: a sensitive biomarker for evaluating disease activity in Crohn's disease with low hs-CRP. [2022]