Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06041269 | A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) | PHASE2 | ACTIVE NOT_RECRUITING | 420 | — | — | Aug 31, 2023 | May 30, 2025 | Nov 25, 2024 | 92 | United States, Belgium +13 |
The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints
| Arm | Type | Description |
|---|---|---|
| Rosnilimab SC Dose 1 | EXPERIMENTAL | This arm will receive treatment SC |
| Rosnilimab SC Dose 2 | EXPERIMENTAL | This arm will receive treatment SC |
| Rosnilimab SC Dose 3 | EXPERIMENTAL | This arm will receive treatment SC |
| Placebo | PLACEBO_COMPARATOR | This arm will receive Placebo |
| Name | Type | Description |
|---|---|---|
| Rosnilimab | DRUG | PD-1 agonist antibody |
| Placebo | DRUG | Placebo |
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...