| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07148414 | A Study of SPY072 in Rheumatic Disease | PHASE2 | ACTIVE NOT_RECRUITING | 285 | — | — | Aug 21, 2025 | Mar 31, 2028 | Jun 5, 2026 | 64 | United States, Bulgaria +6 |
The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.
The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.
The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.
| Arm | Type | Description |
|---|---|---|
| Rheumatoid Arthritis, Dose Regimen 1 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY072 |
| Rheumatoid Arthritis, Dose Regimen 2 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY072 |
| Psoriatic Arthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Axial Spondyloarthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Rhematoid Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Psoriatic Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Axial Spondyloarthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| SPY002-072 | DRUG | Experimental |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: For rheumatoid arthritis: * Moderate-to-severely active RA as defined by the presence of ≥4 swollen joints (based on 28 joint count) and ≥4 tender joints (based on 28 joint count) at Screening and Day 1. * Documentation of ≥1 of the following: 1. Positive test results for rh...