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Recruiting Phase 1/2 NCT06693908

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

Phase 1/2 – combined early trial
Conditions: Moderate to Severe Ulcerative Colitis

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
Who can participate
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
Interventions
Vixarelimab
DRUG
Locations 1
Germany (1)
Charité Research Organisation GmbH
Berlin
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
31.03.2025
Completion date
16.08.2026
Registry ID
NCT06693908
Source
clinicaltrials.gov
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