A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

  • Autoimmune Disorder
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis
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
Country
  • United States
Trial Identifier:

NCT06589986 2024-513014-35-00 GA45329

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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 III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT06589986, GA45329, 2024-513014-35-00 Trial Identifier
      RO7790121, Placebo Treatments
      Moderately to Severely Active Ulcerative Colitis Condition
      Official Title

      A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

      Eligibility Criteria

      All Gender
      ≥16 Years & ≤ 80 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Confirmed diagnosis of UC
      • Moderately to severely active UC assessed by mMS
      • Bodyweight >= 40 kilogram (kg)
      • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
      • Males and females of childbearing potential must meet protocol criteria for contraception requirements
      Exclusion Criteria
      • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
      • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
      • Presence of an ostomy or ileoanal pouch
      • Current diagnosis or suspicion of primary sclerosing cholangitis
      • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
      • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
      • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
      • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
      • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
      • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

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

       

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