A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe 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:

Active, not recruiting

This study runs in
Countries
  • Belgium
  • Brazil
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Korea, Republic of
  • Mexico
  • Poland
  • Serbia
  • Taiwan
  • United Kingdom
  • United States
Study Identifier:

NCT06137183 2023-506655-19-00 GA44839

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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, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT06137183, GA44839, 2023-506655-19-00 Study Identifier
      Vixarelimab, Placebo Treatments
      Ulcerative Colitis Condition
      Official Title

      A Phase II, Multicenter Induction Study With an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of UC for at least 3 months
      • Moderately to severely active UC, assessed by mMS
      • Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
      Exclusion Criteria
      • Diagnosis of Crohn's disease or indeterminate colitis
      • Suspicion of ischemic, radiation, microscopic, or infectious colitis
      • Prior colectomy
      • Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor

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

       

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