Open
Actively Recruiting
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
24-5006
Category
GI Disorders
Principal Investigator
Contact
Location
- UCLA Westwood