What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis, such as Vedolizumab, Adalimumab, and Golimumab, which are biologics similar to Vixarelimab, have several known side effects. Vedolizumab can cause headaches, joint pain, and increased risk of infections. Adalimumab and Golimumab, both anti-TNF agents, may lead to injection site reactions, upper respiratory infections, and increased risk of serious infections. Additionally, these treatments can sometimes cause allergic reactions and may increase the risk of certain cancers. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Several monoclonal antibodies and biologics have been approved by the FDA for the treatment of Ulcerative Colitis. These include Vedolizumab, Adalimumab, and Golimumab, which are used to manage moderate to severe UC. Vedolizumab is an integrin receptor antagonist, while Adalimumab and Golimumab are TNF-alpha inhibitors. These treatments aim to reduce inflammation and manage symptoms in patients who have not responded adequately to conventional therapies. Additionally, AJM300, an oral antagonist of α4-integrin, has shown efficacy in clinical trials for moderately active UC, although it is not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Vixarelimab for Ulcerative Colitis patients include: 1) Vedolizumab subcutaneous formulation, which has shown efficacy and safety in Japanese patients with moderate to severe UC. 2) Ustekinumab, which can be used alone or in combination with an immunomodulator for patients who do not respond to initial biologic therapy. 3) Risankizumab, which is another option for second-line therapy in nonresponders to initial biologic treatments.

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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 below

Select...

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

This trial's timeline: 35 days for screening, 48 weeks for treatment, and 4 weeks for reporting.

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 Anti-drug Antibodies (ADAs) to Vixarelimab

Proportion of Participants with Clinical Response

+3 more

Trial 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.

0 / 5Eligibility criteria met

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.