RVT-3101 for Crohn's Disease

Not currently 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

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1.

investor.roivant.com

investor.roivant.com/news-releases/news-release-details/roivant-reports-chronic-period-data-rvt-3101-tuscany-2-phase-2b

Roivant Reports Chronic Period Data for RVT-3101 from the ...

36% Clinical Remission at week 56 (compared with 29% at week 14) · 50% Endoscopic Improvement at week 56 (compared with 36% at week 14) ...

2.

investor.roivant.com

investor.roivant.com/news-releases/news-release-details/telavant-roivant-company-advances-inflammatory-bowel-disease

Telavant, a Roivant Company, Advances Inflammatory Bowel ...

Telavant is developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn's disease.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05910528

Study Details | NCT05910528 | Afimkibart (RO7790121) for ...

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11660281/

Advancing therapeutic frontiers: a pipeline of novel drugs for ...

Two treatment sequences (A and B) involving induction and maintenance doses of RVT-3101 are compared across various outcome measures.

5.

investor.roivant.com

investor.roivant.com/static-files/7eabab02-5d9f-471d-8aaa-4da26c486bcf

RVT-3101 TUSCANY-2 Chronic Period Data Presentation

The data presented here is from the induction and chronic periods of the TUSCANY-2 study and is based on a preliminary analysis of key efficacy ...

6.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/telavant-doses-first-patient-in-crohns-disease-phase-ii-trial/

Telavant doses first patient in Crohn's disease Phase II trial

RVT-3101 is a drug being investigated for other bowel disease indications. In June, Roivant announced positive results from a Phase 2b study ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06819878

NCT06819878 | A Study to Assess the Efficacy and Safety ...

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy ...