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

May 15, 2026 updated by: Genentech, Inc.

A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Research Organisation GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vixarelimab
Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.
Drug: Vixarelimab
Vixarelimab will be administered as per the schedule specified.
Other Names:
  • RO7622888; KPL-716

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Fibroblast Products From Colonic Tissue
Time Frame: Baseline up to approximately 3 months
Baseline up to approximately 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Concentration of Vixarelimab
Time Frame: Up to approximately 3 months
Up to approximately 3 months
Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab
Time Frame: Up to approximately 3 months
Up to approximately 3 months
Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale
Time Frame: Up to approximately 3 months
Up to approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

August 16, 2026

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA45735
  • 2024-516287-29-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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