RVT-3101 for Crohn's Disease

(TAHOE Trial)

Not currently recruiting at 106 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of RVT-3101, an experimental treatment for individuals with moderate to severe Crohn's disease. Crohn's disease causes inflammation in the digestive tract, leading to symptoms such as frequent diarrhea and stomach pain. The trial will compare two different dosing sequences to determine which is most effective. Suitable candidates for this trial include those who have not responded well to at least one other treatment, such as corticosteroids, and continue to experience symptoms like frequent watery stools or abdominal pain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Afimkibart (also known as RVT-3101) has been tested in people with Crohn's disease. In earlier studies, patients received several doses of this treatment, and it was generally well-tolerated. Most side effects were mild, such as headaches or fatigue, while serious side effects were rare. These results come from studies involving patients with moderate to severe Crohn's disease, similar to those in the current trial. Although this treatment remains under investigation, early findings suggest it is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Researchers are excited about Afimkibart (RO7790121) for Crohn's disease because it offers a novel approach compared to existing treatments like anti-TNF drugs. Unlike the standard treatments, which primarily target tumor necrosis factor, Afimkibart works by modulating the immune system differently, potentially reducing inflammation more effectively. This unique mechanism could lead to better symptom management and fewer side effects for patients. Additionally, the flexibility in dosing, with different induction and maintenance options, might make it adaptable for various patient needs.

What evidence suggests that RVT-3101 might be an effective treatment for Crohn's disease?

Research has shown that Afimkibart, also known as RVT-3101, may help treat moderate to severe Crohn's disease. In this trial, participants will receive different induction doses of Afimkibart, followed by maintenance and optional long-term extension doses. Studies have found that this treatment can significantly improve symptoms for patients with this condition. Afimkibart targets and neutralizes a specific protein involved in inflammation. Early results suggest that the benefits of the treatment may outweigh the risks for many patients. While more studies are being conducted to confirm its effectiveness, initial data supports its potential as a helpful treatment option for Crohn's disease patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Group II: Treatment Sequence A; Drug: Afimkibart (RO7790121) 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06819878

NCT06819878 | A Study to Assess the Efficacy and Safety ... A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/crohn-s-disease/a-study-to-assess-the-efficacy-and-safety-of-induction--94939.html

Clinical Study | Crohn's Disease RO7790121 | ForPatients-... A study to assess the effectiveness and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40706613/

Anti-TL1A antibody, afimkibart, in moderately-to-severely ... However, secondary endpoints suggest that afimkibart was associated with a favourable benefit-risk profile, with clinically meaningful ...

4. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/autoimmune-disorder/crohn-s-disease/a-study-to-assess-the-efficacy-and-safety-of-induction--32899.pdf

A study to test the effectiveness and safety of RO7790121 for ... This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06819891

NCT06819891 | A Study to Assess the Efficacy and Safety ... This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known ...

6. forpatients.roche.com forpatients.roche.com/en/trials/autoimmune-disorder/crohn-s-disease/a-study-to-assess-the-efficacy-and-safety-of-induction--94939.html

Clinical Study | Crohn's Disease RO7790121 - ForPatients A study to assess the effectiveness and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease.