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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04058028 | Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | PHASE2 | COMPLETED | 244 | — | — | Feb 19, 2020 | Jul 25, 2023 | Sep 24, 2024 | 147 | United States, Argentina +17 |
SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
| Arm | Type | Description |
|---|---|---|
| Rozibafusp Alfa, Dose A | EXPERIMENTAL | Investigational product solution in vial |
| Rozibafusp Alfa, Dose B | EXPERIMENTAL | Investigational product solution in vial |
| Rozibafusp Alfa, Dose C | EXPERIMENTAL | Investigational product solution in vial |
| Placebo for Rozibafusp Alfa | PLACEBO_COMPARATOR | Placebo Investigational product solution in vial |
| Name | Type | Description |
|---|---|---|
| Rozibafusp Alfa | DRUG | Rozibafusp Alfa will be presented in 5 mL glass vial |
| Placebo for Rozibafusp Alfa | DRUG | Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial |
Inclusion Criteria Screening Visit: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures. * Age ≥ 18 years to ≤ 75 years at screening visit. * Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)...