A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)

Study Overview
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Brief Summary
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RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

Detailed Description
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This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.

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 Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Rosnilimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Aged 18 years or older A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment Key Exclusion Criteria: History of an inflammatory joint disease other than Rheumatoid Arthritis Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator History of cancer within the last 5 years (except for some skin cancers) Any known or suspected condition that would compromise immune status Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 treatment SC | Drug: Rosnilimab<br>* PD-1 agonist antibody<br>* Other names: ANB030;|
| Experimental: Rosnilimab SC Dose 2<br>This arm will receive treatment SC | Drug: Rosnilimab<br>* PD-1 agonist antibody<br>* Other names: ANB030;|
| Experimental: Rosnilimab SC Dose 3<br>This arm will receive treatment SC | Drug: Rosnilimab<br>* PD-1 agonist antibody<br>* Other names: ANB030;|
| Placebo Comparator: Placebo<br>This arm will receive Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 | The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12 |  | Baseline to Week 12 | 
| American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12 |  | Baseline to Week 12 | 

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