What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as anti-TNF agents (e.g., infliximab, adalimumab), ustekinumab, and vedolizumab, have several known side effects. Anti-TNF agents can cause infections, infusion reactions, and the development of antibodies against the drug. Ustekinumab, which targets IL-12 and IL-23, may lead to infections and nasopharyngitis. Vedolizumab, an anti-integrin, can cause headaches, arthralgias, and nasopharyngitis. These side effects are important considerations when choosing a treatment plan for Crohn's Disease.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease. These include anti-TNF agents like infliximab, adalimumab, and certolizumab pegol, which target tumor necrosis factor-alpha to reduce inflammation. Vedolizumab, an integrin inhibitor, prevents leukocyte trafficking to the gut, and ustekinumab, an IL-12/23 inhibitor, blocks cytokine activity involved in the inflammatory process. These treatments are similar in their biologic nature to RVT-3101, an anti-TL1A monoclonal antibody currently under study.

What other types of research exist?

Promising alternatives to RVT-3101 for Crohn's Disease include Ustekinumab (targets IL-12/23p40) and Certolizumab Pegol (targets TNF-alpha). Both have demonstrated efficacy in inducing and maintaining remission in Crohn's Disease patients.

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RVT-3101 for Crohn's Disease (TAHOE Trial)

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 14

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of RVT-3101 aren't specified here but generally could include typical drug reactions like nausea, headaches, allergic reactions, or other symptoms depending on how the body responds to new treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)

Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)

Proportion of Participants Achieving Endoscopic Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Sequence B; Drug: RO7790121 (RVT-3101) Induction dose B, Maintenance dose and OLE doseExperimental Treatment1 Intervention

Group II: Treatment Sequence A; Drug: RO7790121 (RVT-3101) Induction dose A, Maintenance dose and OLE doseExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include anti-TNF agents like infliximab, adalimumab, and certolizumab pegol, which work by neutralizing tumor necrosis factor-alpha (TNF-alpha), a cytokine involved in systemic inflammation. Another emerging treatment, similar to RVT-3101, is the Anti-TL1A Monoclonal Antibody, which targets TL1A, a cytokine that promotes inflammation and fibrosis in the gut. These treatments are crucial for Crohn's Disease patients as they help reduce inflammation, induce and maintain remission, and prevent complications, thereby improving quality of life and reducing the need for surgical interventions.