A Phase 3 interventional study of Nipocalimab and Placebo in Thrombocytopenia, Neonatal Alloimmune, sponsored by Janssen Research & Development, LLC. Recruiting at 21 sites in 12 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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).
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maternal participants will receive nipocalimab Intravenously (IV).
Drug: Nipocalimab
Maternal participants will receive placebo IV.
Drug: Placebo
Nipocalimab will be administered intravenously.
Also known as: JNJ-80202135, JNJ-86507083
Placebo will be administered intravenously.
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.
Time frame: Up to 1 week post birth
Neonate/Fetus With Adjudicated Bleeding
Neonate/fetus With adjudicated bleeding will be reported.
Time frame: Up to 1 Week post birth
Platelet Count at Birth in a Neonate
Platelet count at birth in a neonate will be reported.
Time frame: At birth
Neonate/Fetus with Outcome of Death
Fetus/neonate with outcome of death will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth
Nadir platelet count in a neonate will be reported.
Time frame: Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)
Neonate(s) who require at least one platelet transfusion(s) will be reported.
Time frame: Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus
Number of Platelet transfusion(s) per neonate will be reported.
Time frame: 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.
Time frame: Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding
Neonate/Fetus With adjudicated severe bleeding will be reported.
Time frame: 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.
Time frame: Up to 1 Week post birth
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.
Time frame: 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.
Time frame: From randomization up to 24 weeks postpartum
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 104
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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 52 and 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.
Time frame: Up to Week 24
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Plan to share: Yes — 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
Data sharing details ↗ · innovativemedicine.jnj.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Nipocalimab
Thrombocytopenia, Neonatal Alloimmune
Janssen Research & Development, LLC →