The trial is taking place at:
T

Tyler Research Institute | Tyler, TX

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

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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 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: 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.

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 * Prior treatment with systemic janus kinase (JAK) inhibitors

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

10

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Central trial contact

Reference Study ID Number: GA44839 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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