A Phase 3 interventional study of Nipocalimab and Intravenous immunoglobulins (IVIG) in Thrombocytopenia, Neonatal Alloimmune, sponsored by Janssen Research & Development, LLC. Recruiting at 38 sites in 11 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 assess the efficacy and safety of nipocalimab 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.
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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 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.
Drug: Nipocalimab
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.
Drug: Intravenous immunoglobulins (IVIG) · Drug: Prednisone
Nipocalimab will be administered intravenously.
Also known as: JNJ-80202135, JNJ-86507083, M281
IVIG will be administered intravenously.
Prednisone will be administered orally.
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
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
Neonate with Platelet Count at Birth <10*10^9/L
Platelet count at birth \<10\*10\^9/L in a neonate will be reported.
Time frame: At birth
Neonate with Platelet Count at Birth <30*10^9/L
Platelet count at birth \<30\*10\^9/L in a neonate will be reported.
Time frame: At birth
Neonate with Platelet Count at Birth <50*10^9/L
Platelet count at birth \<50\*10\^9/L in a neonate will be reported.
Time frame: At birth
Neonate with Platelet Count at Birth <150*10^9/L
Platelet count at birth \<150\*10\^9/L in a neonate will be reported.
Time frame: At birth
Nadir Platelet Count in a Neonate
Nadir platelet count in a neonate will be reported.
Time frame: Up to 1 Week post birth
Neonate Requiring Platelet Transfusion
Neonate who require at least one platelet transfusion will be reported.
Time frame: Up to 1 Week post birth
Number of Platelet Transfusions in Neonate
Number of platelet transfusions per neonate will be reported.
Time frame: Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusions in Neonate
Number of donor exposures for a neonate who received at least one platelet transfusion 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
Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia
Neonate requiring IVIG for the treatment of thrombocytopenia will be reported.
Time frame: Up to 1 Week post birth
Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)
Maternal participant with TEAE, SAE and 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.
Time frame: Up to Week 24
Maternal Participant with TEAE Leading to Discontinuation of Study Intervention
Maternal participant with TEAE leading to discontinuation of study intervention will be reported.
Time frame: Up to Week 24
Neonate/Infant With TEAE, SAE and AESI
Neonate/infant with TEAE, SAE and AESI 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.
Time frame: From Day of birth to Week 104
Fetus/Neonate with a TEAE of Bleeding
Fetus/Neonate with a TEAE of bleeding will be reported.
Time frame: From Day of birth to Week 104
Neonate with a TEAE of Infection
Neonate with a TEAE of infection will be reported.
Time frame: From Day of birth to Week 104
Bayley Scales Assessment for Infant Development
The Bayley Scales of infant development is considered the standard assessment of early child development and includes cognition, language, motor skills, social emotional, and adaptive behavior will be reported. The Bayley Scales are reference standards that measure infant and toddler development in five areas: cognition, language, motor skills, social-emotional and adaptive behavior. The cognition, language and 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. Higher scores in the Bayley Scales indicate better outcomes.
Time frame: At Week 52 and Week 104
Maternal Participants with Incidence of Antibodies to Nipocalimab
Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.
Time frame: Up to Week 4
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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 ↗ · www.jnj.com
Started Feb 2025 (actual). Primary completion is estimated for Dec 2027, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
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 drugs tested here: Nipocalimab · Immunoglobulins, Intravenous
Thrombocytopenia, Neonatal Alloimmune
Janssen Research & Development, LLC →