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

Genentech, Inc.24 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Moderate to Severe Ulcerative Colitis

Interventions

VixarelimabDRUG

Vixarelimab will be administered as per the schedule specified.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité Research Organisation GmbH

Berlin, Germany

Outcomes

Primary Outcomes

Change From Baseline in Fibroblast Products From Colonic Tissue

Time frame: Baseline up to approximately 3 months

Secondary Outcomes

Serum Concentration of Vixarelimab

Time frame: Up to approximately 3 months

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

Time frame: 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

Data from ClinicalTrials.gov

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