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

Genentech

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Vixarelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06137183

GA44839

2023-506655-19-00 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Vixarelimab Dose Regimen 1

Experimental group

Description:

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

Treatment:

Drug: Vixarelimab

Vixarelimab Dose Regimen 2

Experimental group

Description:

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

Treatment:

Drug: Vixarelimab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Vixarelimab

Drug: Placebo