Rheumatoid Arthritis
Conditions
Keywords
PD-1 Agonist, ANB030, RENOIR, Rosnilimab
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.
Interventions
DRUGRosnilimab
PD-1 agonist antibody
DRUGPlacebo
Placebo
Sponsors
AnaptysBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Belgium, Canada, Estonia, France, Georgia, Germany, Hungary, Italy, Moldova, Poland, Slovakia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed