Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06693908

A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Moderate to Severe Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vixarelimab

Drug

Vixarelimab will be administered as per the schedule specified.

Other names: RO7622888; KPL-716

Primary outcomes

  1. Change From Baseline in Fibroblast Products From Colonic Tissue

    Time frame: Baseline up to approximately 3 months

Secondary outcomes

  1. Serum Concentration of Vixarelimab

    Time frame: Up to approximately 3 months

  2. Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab

    Time frame: Up to approximately 3 months

  3. 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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.