A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-1)

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

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).

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia, Neonatal Alloimmune
• Intervention / Treatment: Drug: Placebo; Drug: Nipocalimab

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
• Brazil
  • Recife, Brazil, 50070-902
    • Recruiting
    • Instituto de Medicina Integral Professor Fernando Figueira
  • Rio de Janeiro, Brazil, 22281 00
    • Recruiting
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 05403 000
    • Recruiting
    • Hospital das Clinicas da Faculdade de Medicina da USP
• France
  • Lille, France, 59000
    • Recruiting
    • CHRU Lille
  • Paris, France, 75012
    • Recruiting
    • Hopital trousseau- APHP
• Hungary
  • Budapest, Hungary, 1082
    • Recruiting
    • Semmelweis Egyetem
• Israel
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Sheba Medical Center
• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A Gemelli IRCCS
• Norway
  • Bergen, Norway, 5009
    • Recruiting
    • Haukeland University Hospital
  • Oslo, Norway, 0455
    • Recruiting
    • Oslo University Hospital HF Ulleval sykehus
  • Tromsø, Norway, 9019
    • Recruiting
    • Universitetssykehuset Nord-Norge HF
  • Trondheim, Norway, 7030
    • Recruiting
    • St. Olavs Hospital
• Slovakia
  • Košice, Slovakia, 04190
    • Recruiting
    • Univerzitna nemocnica L. Pasteura Kosice
  • Martin, Slovakia, 036 01
    • Recruiting
    • Univerzitna nemocnica MARTIN
  • Nové Zámky, Slovakia, 940 34
    • Recruiting
    • Fakultna nemocnica s poliklinikou Nove Zamky
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Univerzitetni klinicni center Ljubljana
• Spain
  • Seville, Spain, 41013
    • Recruiting
    • Hosp. Virgen Del Rocio
• Sweden
  • Stockholm, Sweden, SE-141 86
    • Recruiting
    • Karolinska Universitetssjukhuset Huddinge
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
• Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records
• Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
• Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
• For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

• Currently pregnant with multiple gestations (twins or more)
• History of severe preeclampsia in a previous pregnancy
• History of myocardial infarction, unstable ischemic heart disease, or stroke
• Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
• Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nipocalimab; Maternal participants will receive nipocalimab Intravenously (IV).	Drug: Nipocalimab; Nipocalimab will be administered intravenously.; Other Names: JNJ-80202135; JNJ-86507083
Placebo Comparator: Placebo; Maternal participants will receive placebo IV.	Drug: Placebo; Placebo will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L	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.	Up to 1 week post birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonate/Fetus With Adjudicated Bleeding	Neonate/fetus With adjudicated bleeding will be reported.	Up to 1 Week post birth
Platelet Count at Birth in a Neonate	Platelet count at birth in a neonate will be reported.	At birth
Neonate/Fetus with Outcome of Death	Fetus/neonate with outcome of death will be reported.	Up to 1 Week post birth
Platelet Count at Birth <10×10^9/L in a Neonate	Platelet count at birth <10×10^9/L in a neonate will be reported.	At birth
Platelet Count at Birth <30×10^9/ L In a Neonate	Platelet count at birth <30×10^9/L in a neonate will be reported.	At birth
Platelet Count at Birth <50×10^9/L In a Neonate	Platelet count at birth <50×10^9/L in a neonate will be reported.	At birth
Platelet Count at Birth <150×10^9/L In a Neonate	Platelet count at birth <150×10^9/L in a neonate will be reported.	At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth	Nadir platelet count in a neonate will be reported.	Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)	Neonate(s) who require at least one platelet transfusion(s) will be reported.	Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus	Number of Platelet transfusion(s) per neonate will be reported.	Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus	Number of donor exposures for neonates who received platelet transfusion(s) will be reported.	Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding	Neonate/Fetus With adjudicated severe bleeding will be reported.	Up to 1 week post birth
Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia	Neonates with IVIG for the treatment of thrombocytopenia will be reported.	Up to 1 Week post birth
Fetus/Neonate With TEAE of Bleeding	Fetus/Neonate with TEAE of Bleeding will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 104
Neonate With TEAE of Infection	Neonate with TEAE of Infection will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 104
Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum	Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.	Up to Week 24
Maternal Participants With Treatment-Emergent Adverse Event (TEAE)	Maternal participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	From randomization up to 24 weeks postpartum
Maternal Participants With Serious Adverse Event (SAE)	Maternal participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important.	From randomization up to 24 weeks postpartum
Maternal Participants with TEAE Leading to Discontinuation of Study Intervention	Maternal participants with TEAE leading to discontinuation of study intervention will be reported.	Up to Week 104
Neonate/Infant with TEAE	Neonatal/infant participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 104
Neonate/Infant with SAE	Neonatal/infant participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically Important.	Up to Week 104
Neonate/Infant with AESI	Neonatal/infant participants with AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as: In infants- clinically significant mortalities in fetus/neonates due to maternal infections, and hypogammaglobulinemia.	Up to Week 104
Infant Development as Measured by Bayley Scales at Week 52 and Week 104	The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, motor skills scales are directly administered to the infant, while social-emotional, and adaptive behavior scales are caregiver questionnaires. The scores are standardized using norm reference samples with representative demographics and age adjusted for prematurity.	At Week 52 and 104
Maternal Participants With Adverse Event of Special Interest (AESI)	Maternal participants with an AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and/or pulmonary embolism, and clinically significant bleeding.	From randomization up to 24 weeks postpartum

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): December 5, 2029
• Study Completion (Estimated): December 5, 2029

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Infant, Newborn, Diseases; Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Thrombocytopenia, Neonatal Alloimmune; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 80202135FNAIT3001 (Other Identifier: Janssen Research & Development, LLC); 2023-504307-88-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No