Rosnilimab for Ulcerative Colitis

Recruiting at 130 trial locations

Overseen By Kerry Clancy

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

132 Participants Needed

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.

Research Team

Zurab Machaidze, MD

Principal Investigator

AnaptysBio, Inc.

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.

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

Treatment Details

Interventions

• Rosnilimab

Trial Overview 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.

Participant Groups

Group I: Rosnilimab SC Dose 2 Experimental Treatment 1 Intervention

This arm will receive low dose Rosnilimab SC

Group II: Rosnilimab SC Dose 1 Experimental Treatment 1 Intervention

This arm will receive High dose Rosnilimab SC

Group III: Placebo Placebo Group 1 Intervention

This arm will receive Placebo SC

Who Is Running the Clinical Trial?

AnaptysBio, Inc.

Lead Sponsor

Trials

17

Recruited

1,700+