A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis

  • 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:

Recruiting

This study runs in
Country
  • Germany
Study Identifier:

NCT06693908 GA45735

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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

      This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).

      Genentech, Inc. Sponsor
      Phase 1/Phase 2 Phase
      NCT06693908, GA45735 Study Identifier
      Vixarelimab Treatments
      Moderate to Severe Ulcerative Colitis Condition
      Official Title

      A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis

      Eligibility Criteria

      gender
      All Gender
      age
      ≥18 Years Age
      healthy-volunteers
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of UC established at least 3 months
      • Moderately to severely active UC
      • Participants must meet criteria for either advanced therapy failure or conventional therapy failure
      Exclusion Criteria
      • Diagnosis of Crohn's disease or indeterminate colitis
      • Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
      • Prior colectomy
      • Prior treatment with systemic janus kinase (JAK) inhibitors

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

       

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