What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis that target inflammatory pathways, such as monoclonal antibodies, include anti-TNF agents (infliximab, adalimumab), ustekinumab, and vedolizumab. Known side effects of these treatments often include increased risk of infections, nasopharyngitis, headache, and injection site reactions. More serious but less common side effects can include hypersensitivity reactions, liver enzyme abnormalities, and increased risk of certain cancers. Patients should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Several monoclonal antibodies and biologics have been approved by the FDA for the treatment of Ulcerative Colitis, targeting various inflammatory pathways. These include infliximab (Remicade), adalimumab (Humira), and vedolizumab (Entyvio). Infliximab and adalimumab are anti-TNF agents that help reduce inflammation by inhibiting tumor necrosis factor-alpha. Vedolizumab is an integrin receptor antagonist that blocks the migration of T-lymphocytes to inflamed gut tissue. These treatments have shown efficacy in inducing and maintaining remission in patients with moderate to severe Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Rosnilimab for Ulcerative Colitis patients include Ozanimod, a sphingosine-1-phosphate receptor modulator, and IL-23p19 inhibitors, which have shown positive results in phase 2/3 trials. These agents offer new therapeutic options and can be used as first-line or subsequent treatments.

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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 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

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

0 / 2Eligibility criteria met

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.