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Monoclonal Antibodies
Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis
Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of UC for at least 3 months
Moderately to severely active UC, assessed by mMS
Must not have
Have you been diagnosed with Crohn's Disease?
Extensive colonic resection, presence of ileostomy or colostomy
Timeline
Screening 35 days
Treatment 48 weeks
Follow Up 4 weeks
Summary
This trial is testing a new medication called vixarelimab to help people with moderate to severe Ulcerative Colitis who haven't had success with other treatments. The study will check if the medication can reduce symptoms and help patients feel better over time.
Who is the study for?
This trial is for people who have been living with ulcerative colitis (UC) for at least three months. It's specifically aimed at those whose UC is moderate to severe and haven't had success with, or can't tolerate, standard or advanced treatments.
What is being tested?
The study tests Vixarelimab against a placebo in participants with moderate to severe UC. The goal is to see if Vixarelimab is effective, safe, and how the body processes it compared to a non-active treatment.
What are the potential side effects?
While specific side effects of Vixarelimab are not listed here, common side effects from drugs treating UC may include headache, nausea, fever, infections and potential injection site reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ulcerative colitis for at least 3 months.
Select...
My ulcerative colitis is moderate to severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 35 days2 visits
Treatment ~ 48 weeks24 visits
Follow Up ~ 4 weeks2 visits
Screening ~ 35 days
Treatment ~ 48 weeks
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants with Clinical Remission
Secondary study objectives
Number of Participants With Adverse Events (AE) by Severity
Proportion of Participants with Clinical Response
Proportion of Participants with Endoscopic Improvement
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vixarelimab Dose Regimen 2Experimental Treatment1 Intervention
Participants will receive vixarelimab SC during the induction period and the optional ATE period.
Group II: Vixarelimab Dose Regimen 1Experimental Treatment1 Intervention
Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ulcerative Colitis (UC) work by targeting specific pathways involved in inflammation. Monoclonal antibodies like Vixarelimab target OSMRβ to reduce inflammation by blocking signaling pathways that promote it.
Other treatments include 5-aminosalicylic acid (5-ASA) drugs, which act directly in the colon to reduce inflammation, and corticosteroids, which suppress the immune response. Biologics such as anti-TNF agents and integrin inhibitors also target specific molecules to mitigate inflammation.
Understanding these mechanisms helps tailor treatments to individual patients, improving efficacy and minimizing side effects.
AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.
AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,564 Previous Clinical Trials
570,436 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
701 Patients Enrolled for Ulcerative Colitis
Clinical TrialStudy DirectorGenentech, Inc.
9 Previous Clinical Trials
2,060 Total Patients Enrolled
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