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A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Study acronym: FREESIA-1
StatusRecruiting
PhasePhase 3
Started2024-11-11
View on ClinicalTrials.gov ↗
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Amendment record

Amended 28 times since 2024-06-04; 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 2026-08-29.

2026-08-27
Amendment Study Status, Contacts/Locations v28
2026-07-23
Amendment Study Status, Eligibility v27
2026-07-02
Amendment Study Status, Contacts/Locations v26
2026-06-04
Amendment Study Status v25
2026-05-07
Amendment Study Status v24
2026-04-09
Amendment Study Status v23
2026-03-11
Amendment Study Status v22
2026-02-12
Amendment Study Status v21
2026-01-15
Amendment Study Status v20
2025-12-04
Amendment Study Status, Contacts/Locations v19
2025-11-06
Amendment Study Status v18
2025-10-09
Amendment Study Status v17
2025-09-11
Amendment Study Status v16
2025-07-17
Amendment Study Status v15
2025-05-14
Amendment Study Status, Arms and Interventions, Outcome Measures, Eligibility v14
2025-04-25
Amendment Study Status, Contacts/Locations v13
2025-04-24
Amendment Study Status v12
2025-03-27
Amendment Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
2025-02-28
Amendment Study Status, Contacts/Locations v10
2025-02-27
Amendment Study Status v9
2025-01-08
Amendment Study Status v8
2024-12-04
Amendment Study Status v7
2024-11-22
Amendment Study Identification, Study Status, Outcome Measures, Contacts/Locations, IPDSharing v6
2024-10-08
Amendment Study Status, Contacts/Locations v5
2024-09-30
Amendment Study Status, Contacts/Locations v4
2024-09-10
Amendment Study Status, Contacts/Locations v3
2024-07-23
Amendment Study Status, Outcome Measures, Eligibility v2
2024-06-18
Amendment Study Status, Contacts/Locations v1
2024-06-04
Original filing
Trial Details
NCT Number NCT06449651
Lead Sponsor Janssen Research & Development, LLC
Conditions Thrombocytopenia, Neonatal Alloimmune
Enrollment 39 participants
Start Date 2024-11-11
Primary Completion 2029-12-05 (estimated)
Study Completion 2029-12-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-28