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RVT-3101 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 week 54
Awards & highlights

Study Summary

This trial will test how safe and effective a new medicine is for adults with Crohn's disease.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 54 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
PK Parameters of RVT-3101
Proportion of participants achieving clinical remission by CDAI and endoscopic response
+5 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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,141 Total Patients Enrolled
Telavant, Inc.Lead Sponsor
5 Previous Clinical Trials
404 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,858 Total Patients Enrolled

Media Library

RVT-3101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05910528 — Phase 2
Crohn's Disease Research Study Groups: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose, Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose
Crohn's Disease Clinical Trial 2023: RVT-3101 Highlights & Side Effects. Trial Name: NCT05910528 — Phase 2
RVT-3101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910528 — Phase 2

Frequently Asked Questions

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

Is geriatric participation welcomed for this research?

"This trial is available for individuals aged 18 to 75. Ancillary studies exist for those under the age of 18 with 72 participants, and 200 patients over 65 are also partaking in related trials."

Answered by AI

Is Treatment Sequence A with drug RVT-3101 at the Induction dose A and Maintenance dose safe for human usage?

"The safety of Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose has been rated a 2 on the 1 to 3 scale. This is due to Phase 2 trial data which suggests some evidence of its safety, but not yet efficacy."

Answered by AI

How many volunteers have signed up for this research project?

"Affirmative. According to the details published on clinicaltrials.gov, this trial has been actively recruiting since June 30th 2023 and is still looking for participants. Currently, 105 patients are needed from one medical centre."

Answered by AI

Does my medical history qualify me to be a participant in this research program?

"A maximum of 105 individuals between the ages 18 and 75, who are suffering from Crohn's disease that has not responded to previous therapies (such as corticosteroids), can participate in this clinical trial. To be eligible, they must have an elevated rate of soft/liquid stool frequency or abdominal pain according to CDAI and SES-CD measurements conducted by a centralized source. Furthermore, any diagnosis other than Ulcerative colitis, Indeterminate Colitis, Microscopic Colitis, Ischemic Colitis Infectious Colitis Radiation Colitis or Active Diverticular Disease will render them ineligible for inclusion in the"

Answered by AI

Are there any vacancies for participants in this research experiment?

"Currently, this medical trial is seeking to include more participants. The study was initially listed on June 30th 2023 and underwent revision one day prior."

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/NCT05910528.
All > Crohns Disease
~4 spots leftby Jul 2024
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