A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis

NCT ID: NCT06693908

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-06-30

Brief Summary

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This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).

Detailed Description

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Conditions

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Moderate to Severe Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vixarelimab

Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.

Group Type EXPERIMENTAL

Vixarelimab

Intervention Type DRUG

Vixarelimab will be administered as per the schedule specified.

Interventions

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Vixarelimab

Vixarelimab will be administered as per the schedule specified.

Intervention Type DRUG

Other Intervention Names

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RO7622888; KPL-716

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of UC established at least 3 months
* Moderately to severely active UC
* Participants must meet criteria for either advanced therapy failure or conventional therapy failure

Exclusion Criteria

* Diagnosis of Crohn's disease or indeterminate colitis
* Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
* Prior colectomy
* Prior treatment with systemic janus kinase (JAK) inhibitors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Charité Research Organisation GmbH

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Reference Study ID Number: GA45735 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S.)

Other Identifiers

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2024-516287-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

GA45735

Identifier Type: -

Identifier Source: org_study_id

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