> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-efficacy-and-safety-of-rosnilimab-in-subjects-8b4c8246-64a9-45a6-a739-87d6dbd956c2 > Record changed: 2026-10-13 # A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) NCT06041269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Participants 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Lead sponsor AnaptysBio, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Start date 2023-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) Number of sites 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Title and summary **Summary** RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Short title** A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Dates **Completion date** 2025-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **First posted** 2023-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Registry last updated** 2024-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Primary completion date** 2024-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Start date** 2023-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Size and sites **Participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Planned participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Number of sites** 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Lead sponsor** AnaptysBio, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Identifiers **Registry ID** NCT06041269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **ClinicalTrials.gov ID** NCT06041269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Outcomes ### Primary outcomes 1. Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 Timeframe: Baseline to 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 ### Secondary outcomes 1. American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12 Timeframe: Baseline to Week 12 2. American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12 Timeframe: Baseline to Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Sites - AnaptysBio Investigative Site 10-132Flagstaff, United States - AnaptysBio Investigative Site 10-130Glendale, United States - AnaptysBio Investigative Site 10-129Phoenix, United States - AnaptysBio Investigative Site 10-131Tucson, United States - AnaptysBio Investigative Site 10-105Covina, United States - Anaptys Bio Investigative Site 10-119Rancho Mirage, United States - AnaptysBio Investigative Site 10-113San Diego, United States - AnaptysBio Investigative Site 10-127San Francisco, United States - AnaptysBio Investigative Site 10-136Temecula, United States - AnaptysBio Investigative Site 10-133Upland, United States - AnaptysBio Investigative Site 10-112Whitter, United States - AnaptysBio Investigative Site 10-103Aventura, United States - AnaptysBio Investigative Site 10-141Avon Park, United States - AnaptysBio Investigative Site 10-118Boynton Beach, United States - AnaptysBio Investigative Site 10-125Daytona Beach, United States - AnaptysBio Investigative Site 10-122Homestead, United States - Anaptys Bio Investigative Site 10-142Miami, United States - AnaptysBio Investigative Site 10-140Miami, United States - AnaptysBio Investigative Site 10-102Miami, United States - AnaptysBio Investigative Site 10-124Plantation, United States - AnaptysBio Investigative Site 10-139West Palm Beach, United States - AnaptysBio Investigative Site 10-114Chicago, United States - AnaptysBio Investigative Site 10-145Monroe, United States - AnaptysBio Investigative Site 10-143Brookline, United States - AnaptysBio Investigative Site 10-116Albuquerque, United States And 67 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06041269) ## Related records ### Drugs (1) - [Rosnilimab](https://trialight.com/data/asset/rosnilimab-8ca98c26-a5b2-49fc-be53-027947c36ad5.md) ### Lead sponsors (1) - [AnaptysBio, Inc.](https://trialight.com/data/company/anaptysbio-inc-813123ab-4b87-4755-b23a-ace89f039007.md) ### Conditions (1) - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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