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
Not yet recruiting
NCT06137183 2023-506655-19-00 GA44839
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.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics 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.
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
- 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
- Diagnosis of Crohn's disease or indeterminate colitis
- Suspicion of ischemic, radiation, microscopic, 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