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A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Study acronym: FREESIA-3
StatusRecruiting
PhasePhase 3
Started2025-02-10
View on ClinicalTrials.gov ↗
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Amendment record

Amended 29 times since 2024-07-30; most recent filed 2026-08-27. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-08-27
Amendment Study Status, Contacts/Locations v29
2026-07-02
Amendment Study Status, Contacts/Locations v28
2026-06-04
Amendment Study Status, Contacts/Locations v27
2026-05-22
Amendment Study Identification, Study Status, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v26
2026-05-07
Amendment Study Status v25
2026-04-09
Amendment Study Status, Contacts/Locations v24
2026-03-12
Amendment Study Status, Contacts/Locations v23
2026-02-12
Amendment Study Status, Contacts/Locations v22
2026-01-15
Amendment Study Status, Contacts/Locations v21
2025-12-04
Amendment Study Status, Contacts/Locations v20
2025-11-06
Amendment Study Status, Contacts/Locations v19
2025-10-09
Amendment Study Status v18
2025-09-11
Amendment Study Status v17
2025-08-19
Amendment Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v16
2025-07-17
Amendment Study Status v15
2025-06-20
Amendment Study Status, Contacts/Locations v14
2025-05-22
Amendment Study Status v13
2025-04-25
Amendment Study Status, Contacts/Locations v12
2025-04-02
Amendment Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
2025-03-03
Amendment Study Status, Contacts/Locations v10
2025-02-27
Amendment Study Status v9
2025-02-07
Amendment Study Status v8
2025-01-30
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
2025-01-09
Amendment Study Status, Contacts/Locations v6
2024-12-13
Amendment Study Identification, Study Status, Oversight, Outcome Measures, Eligibility, IPDSharing v5
2024-12-04
Amendment Study Status v4
2024-10-08
Amendment Study Status v3
2024-09-10
Amendment Study Status v2
2024-08-13
Amendment Study Status v1
2024-07-30
Original filing
Trial Details
NCT Number NCT06533098
Lead Sponsor Janssen Research & Development, LLC
Conditions Thrombocytopenia, Neonatal Alloimmune
Enrollment 50 participants
Start Date 2025-02-10
Primary Completion 2027-12-15 (estimated)
Study Completion 2029-12-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-28