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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

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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
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Contact
Xiaoxiao Yin
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06137183
For detailed technical eligibility, visit ClinicalTrials.gov.