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

Autoimmune Disorder
Inflammatory Bowel Disease (IBD)
Ulcerative Colitis

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1/Phase 2

Trial Identifier NCT06693908, GA45735

Condition Moderate to Severe Ulcerative Colitis

Official 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

Study Summary

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

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com