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Monoclonal Antibodies

Rosnilimab for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by AnaptysBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a clinical diagnosis of UC for prior to Day 1

Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Study Summary

This trial will study a new drug to see if it can help people with UC, looking at safety, effectiveness, and how well it is tolerated.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects of Rosnilimab may include reactions at the injection site, increased risk of infections, headaches, nausea, and potential immune system-related issues. Placebo group risks are minimal but can include similar symptoms due to the body's natural response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in modified Mayo Score (mMs) from Baseline to Week 12

Secondary outcome measures

Proportion of subjects achieving a clinical response at Week 12

Proportion of subjects achieving clinical remission at Week 12

Proportion of subjects showing endoscopic treatment improvement at Week 12

Trial Design

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor

16 Previous Clinical Trials

1,516 Total Patients Enrolled

Zurab Machaidze, MDStudy DirectorAnaptysBio, Inc.

1 Previous Clinical Trials

87 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Rosnilimab SC Dose 1 a safe and viable option for patients?

"Our team at Power assessed Rosnilimab SC Dose 1's safety as a 2 on the scale of 1 to 3. As this is only in Phase 2, there are reports affirming its security but no evidence yet attesting to its efficacy."

Answered by AI

Are participants welcome to join this research endeavor at present?

"It appears that this medical study is no longer recruiting, as the most recent update to their clinicaltrials.gov listing was dated November 7th 2023. Nevertheless, there are still 445 other trial opportunities available for prospective participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

2023. "A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127043.

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