Rosnilimab for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AnaptysBio, Inc.

Must not be taking: Anti-TNF, Biologics, JAK inhibitors, S1P modulators

Disqualifiers: Crohn's disease, Fulminant colitis, Colectomy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called Rosnilimab to see if it can help people with moderate to severe ulcerative colitis. The study will check if the medication is safe and if it works well to reduce inflammation in the colon. Researchers want to find out if Rosnilimab can improve symptoms for those who haven't had success with other treatments.

Do I need to stop my current medications for the trial?

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 adults over 18 with moderate to severe active ulcerative colitis, confirmed by a recent colonoscopy. Participants should have been diagnosed before Day 1 of the study and show specific scores on medical scales that measure UC severity.

Inclusion Criteria

I am 18 years old or older.

My ulcerative colitis is active and severe, confirmed by a test.

I was diagnosed with ulcerative colitis before the study start date.

+1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rosnilimab or placebo for 12 weeks to evaluate efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The ROSETTA study is testing Rosnilimab's effectiveness and safety in treating ulcerative colitis compared to a placebo. The goal is to see if Rosnilimab can help manage symptoms better than no treatment at all.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Rosnilimab SC Dose 2Experimental Treatment1 Intervention

This arm will receive low dose Rosnilimab SC

Group II: Rosnilimab SC Dose 1Experimental Treatment1 Intervention

This arm will receive High dose Rosnilimab SC

Group III: PlaceboPlacebo Group1 Intervention

This arm will receive Placebo SC