Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis

Recruiting at 142 trial locations

Overseen By Reference Study ID Number: GA44839 https://forpatients.roche.com/

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must not be taking: JAK inhibitors

Disqualifiers: Crohn's disease, Colectomy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

79 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Who Is on the Research Team?

Clinical Trial

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

inadecuate /los of response to advance or conventional treatment

My ulcerative colitis is moderate to severe.

I have been diagnosed with ulcerative colitis for at least 3 months.

Exclusion Criteria

Have you been diagnosed with Crohn's Disease?

Extensive colonic resection, presence of ileostomy or colostomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive vixarelimab or placebo to test the induction of clinical remission

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Active Treatment Extension (optional)

Participants receive vixarelimab to explore durability of clinical response and remission

Up to 44 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vixarelimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Vixarelimab Dose Regimen 2 Experimental Treatment 1 Intervention

Participants will receive vixarelimab SC during the induction period and the optional ATE period.

Group II: Vixarelimab Dose Regimen 1 Experimental Treatment 1 Intervention

Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.

Group III: Placebo Placebo Group 2 Interventions

Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD