| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04669600 | A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP) | PHASE2 | COMPLETED | 12 | — | — | Feb 4, 2021 | Feb 7, 2023 | Sep 10, 2025 | 9 | United States, Czechia +4 |
A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was \>=30 × 10\^9/L at \>=50% of scheduled visits, without receiving rescue ITP therapy.
| Arm | Type | Description |
|---|---|---|
| SAR445088 | EXPERIMENTAL | Participants received SAR445088 (BIVV020). |
| Name | Type | Description |
|---|---|---|
| SAR445088 (BIVV020) | DRUG | Pharmaceutical form:solution for injection |
Inclusion criteria : * Male and female participants ≥18 years of age at the time of signing the informed consent * Confirmed diagnosis of primary ITP; for participants who previously received sutimlimab in study TDR16218 (NCT03275454), a response to sutimlimab must have been obtained, as defined by...