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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
Summary
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.
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.
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.
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 belowSelect...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in modified Mayo Score (mMs) from Baseline to Week 12
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibodies, such as Rosnilimab, target specific inflammatory pathways to reduce inflammation in Ulcerative Colitis (UC). These biologic agents work by inhibiting cytokines like TNF-alpha or interleukins, which play a crucial role in the inflammatory process.
By blocking these molecules, monoclonal antibodies help to decrease the immune response that causes the chronic inflammation characteristic of UC. This targeted approach is significant for UC patients as it can lead to more effective management of symptoms and potentially induce and maintain remission, improving their quality of life.
Other common treatments include aminosalicylates, corticosteroids, and immunomodulators, which also aim to reduce inflammation but through different mechanisms, such as inhibiting prostaglandin production or modulating the immune system more broadly.
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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