Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+136 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Genentech, Inc.

Must not be taking: JAK inhibitors

Disqualifiers: Crohn's disease, Colectomy, others

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

Trial Timeline

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

Participant Groups

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.

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.