RVT-3101 for Crohn's Disease

(TAHOE Trial)

Recruiting at 105 trial locations

Overseen By Suzanne Vyvoda

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Ulcerative colitis, Short gut, 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

21 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug RVT-3101 different from other drugs for Crohn's disease?

RVT-3101 is unique because it may offer a new approach to managing Crohn's disease, potentially targeting different pathways or mechanisms compared to existing treatments like anti-tumor necrosis factor-alpha monoclonal antibodies, which are used to delay relapses in responsive patients. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called RVT-3101 in adults with moderate to severe Crohn's disease. The goal is to see if it can reduce inflammation and improve symptoms by calming the immune system.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I often have very soft or liquid stools and/or stomach pain.

I have been diagnosed with a type of colitis or active diverticular disease.

I did not respond well or had side effects from at least one standard treatment.

Exclusion Criteria

I have short gut syndrome.

I have an ostomy or ileoanal pouch.

I had surgery on my intestines about 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive induction dose of RO7790121 (RVT-3101) to evaluate initial safety and efficacy

14 weeks

Maintenance

Participants continue to receive maintenance dose of RO7790121 (RVT-3101) to sustain treatment effects

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RVT-3101

Trial Overview 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.

Participant Groups

Group I: Treatment Sequence B; Drug: RO7790121 (RVT-3101) Induction dose B, Maintenance dose and OLE dose Experimental Treatment 1 Intervention

Group II: Treatment Sequence A; Drug: RO7790121 (RVT-3101) Induction dose A, Maintenance dose and OLE 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

Telavant, Inc.

Lead Sponsor

Trials

6

Recruited

430+

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

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

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

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