A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

  • Autoimmune Disorder
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis
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:

Not yet recruiting

This study runs in
N/A
Trial Identifier:

NCT06979336 2025-520690-39-00 GA45977

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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 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

      The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT06979336, GA45977, 2025-520690-39-00 Trial Identifier
      RO7837195, RO7837195 Matched Placebo Treatments
      Ulcerative Colitis Condition
      Official Title

      A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of ulcerative colitis (UC) established at least 3 months
      • Moderately to severely active UC assessed by mMS
      • Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
      Exclusion Criteria
      • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
      • Diagnosis of Crohn's disease or indeterminate colitis
      • Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
      • Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

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

       

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