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

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: Vixarelimab; Drug: Placebo

• Registration Number: NCT06137183
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2024-05-01
• Status Verified: 2025-06
• Primary Completion: 2025-06-16
• Study Completion: 2025-06-16
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
Vixarelimab Dose Regimen 1	Vixarelimab	Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
Vixarelimab Dose Regimen 2	Vixarelimab	Participants will receive vixarelimab SC during the induction period and the optional ATE period.
Placebo	Vixarelimab	Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Clinical Remission	Week 12	Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Clinical Response	Week 12	Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.
Proportion of Participants With Endoscopic Improvement	Week 12	Endoscopic improvement is defined as a mayo endoscopy subscore of ≤ 1. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Proportion of Participants With Endoscopic Remission	Week 12	Endoscopic remission is defined as a mayo endoscopy subscore of 0. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Number of Participants With Adverse Events (AEs) by Severity	Up to Week 56	The AEs will be graded according to the Division of AIDS (DAIDS) table for grading the severity. The toxicity level is graded from grade 1 (lowest toxicity) to 4 (highest toxicity).
Serum Concentration of Vixarelimab	Up to Week 56
Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab	Up to Week 56

Trial Locations

Locations (122)

Gulf Coast Gatroenterology; 🇺🇸 Fairhope, Alabama, United States

OM Research LLC - Camarillo - ClinEdge - PPDS; 🇺🇸 Camarillo, California, United States

UCLA Clinical and Translational Research Center; 🇺🇸 Los Angeles, California, United States

Facey Medical Foundation - Mission Hills; 🇺🇸 Mission Hills, California, United States

Clinical Applications Laboratories, Inc.; 🇺🇸 San Diego, California, United States

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Regenerate Primary Medical; 🇺🇸 Miami, Florida, United States

Advanced Research Institute, Inc.; 🇺🇸 New Port Richey, Florida, United States

Orlando Gastroenterology, P.A.; 🇺🇸 Orlando, Florida, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

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