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

Study Overview
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Brief Summary
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ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

Detailed Description
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This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Rosnilimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 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 Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon cancer performed within 1 year of Day 1. Exclusion Criteria: Subject has a diagnosis of Crohn's disease or indeterminate colitis. Subject has a diagnosis of fulminant colitis and/or toxic megacolon. Subject has a history of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes but not limited to, 1) anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), 2) other biologics (e.g., ustekinumab, vedolizumab), 3) oral JAK inhibitors (e.g., tofacitinib, upadacitinib), and 4) oral S1P receptor modulators (e.g., ozanimod). Subject has disease limited to the rectum (ulcerative proctitis) Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery. The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosnilimab SC Dose 1<br>This arm will receive High dose Rosnilimab SC | Drug: Rosnilimab<br>* PD-1 agonist antibody<br>* Other names: ANB030;|
| Experimental: Rosnilimab SC Dose 2<br>This arm will receive low dose Rosnilimab SC | Drug: Rosnilimab<br>* PD-1 agonist antibody<br>* Other names: ANB030;|
| Placebo Comparator: Placebo<br>This arm will receive Placebo SC | Drug: Placebo<br>* Administered via SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in modified Mayo Score (mMs) from Baseline to Week 12 | The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving clinical remission at Week 12 | Defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS=0, and endoscopic subscore ≤ 1 without friability. | Baseline to Week 12 | 
| Proportion of subjects showing endoscopic treatment improvement at Week 12 | Defined as an endoscopy subscore ≤ 1 without friability. | Baseline to Week 12 | 
| Proportion of subjects achieving a clinical response at Week 12 | Defined as a decrease from Baseline in mMS ≥ 2 points and ≥ 30% with a decrease from Baseline in RBS ≥ 1 point or an absolute RBS ≤ 1. | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosnilimab, ANB030, PD-1 agonist, ROSETTA