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

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jenny S. Sauk, MD (ucla)
Headshot of Jenny S. Sauk
Jenny S. Sauk

Description

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.

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

Details

This study consists of two periods:

  1. An induction period which will test the induction of clinical remission;
  2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.

Keywords

Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Disease, Colitis, Ulcer, Vixarelimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Clinical and Translational Research Center accepting new patients
    Los Angeles California 90095 United States
  • Clinical Applications Laboratories, Inc. accepting new patients
    San Diego California 92103-5639 United States

Lead Scientist at University of California Health

  • Jenny S. Sauk, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 64 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT06137183
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 210 study participants
Last Updated