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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06533098 | A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) | PHASE3 | RECRUITING | 50 | — | — | Feb 10, 2025 | Dec 5, 2029 | Jun 5, 2026 | 26 | United States, Austria +4 |
| NCT06449651 | A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) | PHASE3 | RECRUITING | 39 | — | — | Nov 11, 2024 | Dec 5, 2029 | Jun 5, 2026 | 21 | Belgium, Brazil +10 |
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Nipocalimab | EXPERIMENTAL | Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery. |
| Arm 2: Intravenous Immunoglobins (IVIG) | EXPERIMENTAL | Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance. |
| Nipocalimab | ACTIVE_COMPARATOR | Maternal participants will receive nipocalimab Intravenously (IV). |
| Placebo | PLACEBO_COMPARATOR | Maternal participants will receive placebo IV. |
| Name | Type | Description |
|---|---|---|
| Nipocalimab | DRUG | Nipocalimab will be administered intravenously. |
| Intravenous immunoglobulins (IVIG) | DRUG | IVIG will be administered intravenously. |
| Prednisone | DRUG | Prednisone will be administered orally. |
| Placebo | DRUG | Placebo will be administered intravenously. |
Inclusion Criteria: * Pregnant and an estimated gestational age (GA) from week 13\* to 18 at visit 1 \*Randomization for high-risk FNAIT participants to occur at GA Week 12 * Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neona...