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

  • Autoimmune Disorder
  • Crohn's Disease
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Countries
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Poland
  • Slovakia
  • Spain
  • United States
Trial Identifier:

NCT05910528 RVT 3101-201

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT05910528,RVT 3101-201 Trial Identifier
      RVT-3101 Treatments
      Crohn Disease Condition
      Official Title

      A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

      Eligibility criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Moderately to severely active CD as defined by Crohn's Disease Activity Index (CDAI) and Simple Endoscopic Score for CD (SES-CD), assessed by central read
      • Elevated very soft or liquid stool frequency and/or abdominal pain
      • Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
      • Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
      Exclusion Criteria
      • Short gut syndrome
      • Presence of an ostomy or ileoanal pouch
      • Bowel resection or diversion with ~6-months

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