A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06041269
- Lead Sponsor
- AnaptysBio, Inc.
- Brief Summary
RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 420
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosnilimab SC Dose 1 Rosnilimab This arm will receive treatment SC Placebo Placebo This arm will receive Placebo Rosnilimab SC Dose 2 Rosnilimab This arm will receive treatment SC Rosnilimab SC Dose 3 Rosnilimab This arm will receive treatment SC
- Primary Outcome Measures
Name Time Method Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (92)
AnaptysBio Investigative Site 20-106
🇮🇹Milan, Lombardy, Italy
AnaptysBio Investigative Site 20-110
🇮🇹Milan, Italy
AnaptysBio Investigative Site 10-132
🇺🇸Flagstaff, Arizona, United States
AnaptysBio Investigative Site 10-130
🇺🇸Glendale, Arizona, United States
AnaptysBio Investigative Site 10-129
🇺🇸Phoenix, Arizona, United States
AnaptysBio Investigative Site 10-131
🇺🇸Tucson, Arizona, United States
AnaptysBio Investigative Site 10-105
🇺🇸Covina, California, United States
Anaptys Bio Investigative Site 10-119
🇺🇸Rancho Mirage, California, United States
AnaptysBio Investigative Site 10-113
🇺🇸San Diego, California, United States
AnaptysBio Investigative Site 10-127
🇺🇸San Francisco, California, United States
Scroll for more (82 remaining)AnaptysBio Investigative Site 20-106🇮🇹Milan, Lombardy, Italy