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Monoclonal Antibodies

Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose for Crohn's Disease

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 up to week 64

Awards & highlights

Study Summary

This trial is testing a new medication called RVT-3101 in adults with moderate to severe Crohn's disease to see if it is safe and effective.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the specific side effects of RVT-3101 aren't listed here, similar medications often cause immune system changes, infections, infusion reactions, liver issues, nausea, headaches, and fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants achieving clinical remission by CDAI

Secondary outcome measures

Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation

Percentage of Participants with Anti-drug antibodies (ADA)

Percentage of Participants with Neutralizing Antibodies (NAb)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance doseExperimental Treatment1 Intervention

Group II: Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance doseExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,113 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,830 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research endeavor?

"To be considered for inclusion in this research, individuals must have a confirmed diagnosis of Crohn's disease and fall between the ages of 18 and 75. The study aims to enroll approximately 20 eligible participants."

Answered by AI

At how many different sites is this medical trial being conducted?

"Patients are currently being enrolled at Medical Research Center of Connecticut, LLC in Hamden, Connecticut, G.I.R.I. GI Research Institute in Vancouver, British Columbia, and Amicis Research Center in Santa Clarita, Alabama. Additionally, recruitment is ongoing across 40 other medical facilities as well."

Answered by AI

Are prospective participants able to enroll in this research study at the present time?

"The information available on clinicaltrials.gov indicates that this specific trial is no longer accepting new participants. Although it was initially posted on July 24th, 2023, the most recent update was made on April 16th, 2024. Despite its closure to enrollment, there are presently 260 alternative trials actively seeking eligible candidates for participation."

Answered by AI

Does this study include individuals aged above 30 years?

"To be eligible for this research, participants must fall between the ages of 18 and 75 years old."

Answered by AI

Is the experimental treatment plan involving RVT-3101, including the initial induction dose and subsequent maintenance doses, currently authorized by the FDA?

"Based on the current evaluation by our team at Power, Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose are rated a 2 for safety. This decision is based on the fact that this trial falls under Phase 2, where some safety data exists but not yet efficacy data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease

2023. "RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06370858.

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