RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease

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

Active, not recruiting

This study runs in
Cities
  • Boston
  • Chesterfield
  • Dothan
  • Hamden
  • Kissimmee
  • Nantes
  • Neuilly-sur-Seine
  • Roeselare
  • Szczecin
  • Vandœuvre-lès-Nancy
  • Warsaw
Trial Identifier:

NCT05910528 2023-504265-23-00 GA45392

  • AZ Delta

    90 Brugsesteenweg8800RoeselareBelgium

  • Brigham and Women's Hospital

    02115BostonUnited States

  • CHRU de Nancy Brabois

    54500Vandœuvre-lès-NancyFrance

  • CHU de Nantes

    44093NantesFrance

  • Clinical Research Institute of Michigan

    30795 23 Mile Rd48047ChesterfieldUnited States

  • Digestive Health Specialists

    265 Medical Park Blvd36301DothanUnited States

  • I.H.S Health Northwell Health

    721 Oak Commons Blvd34741KissimmeeUnited States

  • Institut des MICI, Clinique Ambroise Paré

    27 Bd Victor Hugo92200Neuilly-sur-SeineFrance

  • Medical Research Center of Connecticut, LLC

    06518HamdenUnited States

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    19 Juliusza Słowackiego71-434SzczecinPoland

  • WIP Warsaw IBD Point Profesor Kierkus

    00-728WarsawPoland
    +−
    Show study locations

    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 study 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

    Study Summary

    This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT05910528, GA45392, 2023-504265-23-00 Trial Identifier
    RVT-3101 Treatments
    Crohns Disease Condition
    Official Title

    A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

    Eligibility Criteria

    gender
    All Gender
    age
    ≥18 Years & ≤ 75 Years Age
    healthy-volunteers
    No Healthy Volunteers
    Inclusion Criteria
    • Moderately to severely active CD as defined by CDAI and 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
    Exclusion Criteria
    • Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
    • Short gut syndrome
    • Presence of an ostomy or ileoanal pouch
    • Bowel resection or diversion with ~6-months

    For the latest version of this information please go to www.forpatients.roche.com

     

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