Status:
ACTIVE_NOT_RECRUITING
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
Lead Sponsor:
AnaptysBio, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06041269
Start Date
August 31 2023
End Date
May 30 2025
Last Update
November 25 2024
Active Locations (92)
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1
AnaptysBio Investigative Site 10-132
Flagstaff, Arizona, United States, 86001
2
AnaptysBio Investigative Site 10-130
Glendale, Arizona, United States, 85306
3
AnaptysBio Investigative Site 10-129
Phoenix, Arizona, United States, 85037
4
AnaptysBio Investigative Site 10-131
Tucson, Arizona, United States, 85704