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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137183
• Other study ID #: GA44839
• Secondary ID: 2023-506655-19-0
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GA44839 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 1, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Prior treatment with systemic janus kinase (JAK) inhibitors

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
• Placebo
Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Locations

Country	Name	City	State
Poland	EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu	Wroclaw
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	OM Research LLC - Camarillo - ClinEdge - PPDS	Camarillo	California
United States	Gulf Coast Gatroenterology	Fairhope	Alabama
United States	Carolina Digestive Diseases	Greenville	North Carolina
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	Orlando Gastroenterology, P.A.	Orlando	Florida
United States	Regenerate Primary Medical	South Miami	Florida
United States	Delta Gastroenterology & Endoscopy Center	Southaven	Mississippi
United States	Tyler Research Institute, LLC	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with Clinical Remission	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.	Week 12
Secondary	Proportion of Participants with Clinical Response	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.	Week 12
Secondary	Proportion of Participants with Endoscopic Improvement	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).	Week 12
Secondary	Proportion of Participants with Endoscopic Remission	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).	Week 12
Secondary	Number of Participants With Adverse Events (AE) by Severity	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).	Up to Week 56
Secondary	Serum Concentration of Vixarelimab		Up to Week 56
Secondary	Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab		Up to Week 56