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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137183

Collaborator

(none)

210

Enrollment

Arms

39.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Vixarelimab Drug: Placebo	Phase 2

Detailed Description

This study consists of two periods:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 15, 2024

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vixarelimab Dose Regimen 1 Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.	Drug: Vixarelimab Vixarelimab will be administered as per the schedule specified in the respective arms. Other Names: RO7622888; KPL-716
Experimental: Vixarelimab Dose Regimen 2 Participants will receive vixarelimab SC during the induction period and the optional ATE period.	Drug: Vixarelimab Vixarelimab will be administered as per the schedule specified in the respective arms. Other Names: RO7622888; KPL-716
Placebo Comparator: Placebo Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.	Drug: Vixarelimab Vixarelimab will be administered as per the schedule specified in the respective arms. Other Names: RO7622888; KPL-716 Drug: Placebo Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Arm

Intervention/Treatment

Experimental: Vixarelimab Dose Regimen 1

Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.

Drug: Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

Other Names:

RO7622888; KPL-716

Experimental: Vixarelimab Dose Regimen 2

Participants will receive vixarelimab SC during the induction period and the optional ATE period.

Drug: Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

Other Names:

RO7622888; KPL-716

Placebo Comparator: Placebo

Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Drug: Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

Other Names:

RO7622888; KPL-716

Drug: Placebo

Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Outcome Measures

Primary Outcome Measures

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

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 (AE) 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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