A Phase 3 interventional study of Nipocalimab and Placebo in Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development, LLC. Recruiting at 69 sites in 18 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 effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
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.
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.
History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
Drug: Nipocalimab
Participants will receive matching placebo IV qw from randomization through GA Week 35.
Drug: Placebo
Nipocalimab will be administered as an intravenous infusion.
Also known as: JNJ-80202135, M281, JNJ-86507083
Placebo will be administered as an intravenous infusion.
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(\>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (\>)5 millimeter \[mm\]). PMA is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).
Time frame: From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Number of participants with HDFN by severity will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. Here database lock implies the last participant has given birth or terminated their pregnancy, completed the Week 4 visit after delivery, and whose neonate has also completed the Week 4 visit (or 41 weeks PMA, whichever is later) or died prior to this timepoint.
Time frame: For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth
Time to First Occurrence of IUT or Hydrops Fetalis
Time to first occurrence of IUT or hydrops fetalis will be reported.
Time frame: From randomization to delivery of baby (Up to 38 weeks)
Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates
The NMMI will be assessed with the following categories: fatal: fetal/neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category'
Time frame: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUT's Received During the Pregnancy
Number of IUT's received during the pregnancy will be reported.
Time frame: From randomization to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal Loss
Percentage of pregnancies with fetal loss will be reported.
Time frame: Time to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal or Neonatal Death
Percentage of pregnancies with fetal or neonatal death (through the neonatal period) as a result of HDFN will be reported.
Time frame: Through Week 4 or 41 weeks PMA
Percentage of Pregnancies With Hydrops Fetalis
Percentage of pregnancies with hydrops fetalis will be reported. Hydrops fetalis is defined as the presence of \>=2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness \>5 mm).
Time frame: Up to 41 weeks PMA
Percentage of Pregnancies Receiving IUT During Pregnancy
Percentage of pregnancies receiving IUT during pregnancy will be reported.
Time frame: Up to 35 weeks of GA period
Gestational Age (GA) at First IUT
GA at first IUT will be reported.
Time frame: Up to 35 weeks of GA period
Percentage of Pregnancies Receiving >1 IUT During Pregnancy
Percentage of pregnancies receiving \>1 IUT during pregnancy will be reported.
Time frame: Up to 35 weeks of GA period
Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20
Percentage of pregnancies receiving IUT or HDFN resulting in fetal demise \<GA Week 20 will be reported.
Time frame: Up to 20 weeks
Gestational Age at Delivery
Gestational age at delivery will be reported.
Time frame: Up to 38 weeks
Percentage of Pregnancies With Neonatal Death Through the Neonatal Period
Percentage of pregnancies with neonatal death through the neonatal period will be reported.
Time frame: From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later
Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice
Percentage of liveborn neonates with HDFN-related morbidities other than anemia and hyperbilirubinemia or jaundice will be reported.
Time frame: From day of birth up to 4 weeks
Absolute Weight of Liveborn Neonates or Infants
Absolute weight of liveborn neonates or infants will be reported.
Time frame: Up to 104 weeks
Change From Baseline in Weight of Liveborn Neonates or Infants
Change from baseline in weight of liveborn neonates or infants will be reported.
Time frame: Baseline to up to 104 weeks
Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit
Liveborn neonates length of stay in neonatal intensive care unit will be reported.
Time frame: From day of birth up to 27 days
Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN
Percentage of liveborn neonates receiving exchange transfusions for HDFN will be reported.
Time frame: From day of birth up to 27 days
Number of Neonatal Exchange Transfusions per Liveborn Neonate
Number of neonatal exchange transfusions per liveborn neonate will be reported.
Time frame: From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants with Simple Transfusions for HDFN
Percentage of liveborn neonates or infants with simple transfusions for HDFN through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
Time frame: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Simple Transfusions for HDFN per Liveborn Neonate or Infant
Number of simple transfusions for HDFN per liveborn neonate or infant through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
Time frame: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Percentage of Liveborn Neonates With Hyperbilirubinemia Treated With Phototherapy
Percentage of liveborn neonates with hyperbilirubinemia treated with phototherapy will be reported.
Time frame: From day of birth up to 27 days
Number of Days of Phototherapy Received for Hyperbilirubinemia per Liveborn Neonate
Number of days of phototherapy received for hyperbilirubinemia per liveborn neonate will be reported.
Time frame: From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants Receiving Intravenous Immunoglobulin (IVIg) for HDFN Treatment
Percentage of liveborn neonates or infants receiving IVIg for HDFN treatment will be reported.
Time frame: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Maternal Deaths
Number of maternal deaths will be reported.
Time frame: Form randomization up to 24 weeks postpartum
Number of Participants with Adverse Events (AEs)
Number of participants with AEs, serious adverse events, and AEs of special interest (AESIs), AE's leading to discontinuations, infections, serious infections, infusion reactions, and hypersensitivity reactions will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: hypoalbuminemia, clinically significant bleeding with a corresponding placental finding on ultrasound, maternal infections that led to clinically significant morbidities or mortalities in fetus or neonates, Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention in maternal participants or neonates or infants, and infants with hypogammaglobulinemia.
Time frame: From randomization up to 24 weeks postpartum
Number of Maternal Pregnancy Complications
Number of maternal pregnancy complications will be reported.
Time frame: Up to 38 weeks
Number of IUT Related complications
Number of participants with IUT related complications will be reported.
Time frame: Up to 35 weeks of GA period
Percentage of Pregnancies With Cesarean Delivery, Preterm Birth, Fetal Growth, and Preeclampsia
Percentage of pregnancies with cesarean delivery, cesarean delivery due to IUT complications, preterm birth \<GA week 28, preterm birth \<GA week 32, preterm birth \<GA week 34, preterm birth \<GA week 37, fetal growth restriction, and preeclampsia will be reported.
Time frame: Up to 38 weeks of GA period
Percentage of Liveborn Neonates or Infants Who Died
Percentage of liveborn neonates or infants who died will be reported.
Time frame: Up to 104 weeks
Percentage of Liveborn Neonates or Infants With AEs
Percentage of liveborn neonates or infants with AEs, SAEs, AESIs, infections, serious infections will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. Any event requiring hospitalization (or prolongation of hospitalization) that occurs during participation in the study must be reported as an SAE.
Time frame: Up to 104 weeks
Percentage of Liveborn Neonates or Infants Receiving IVIg for Non-HDFN Indications
Percentage of liveborn neonates or infants receiving IVIg for non-HDFN indications will be reported.
Time frame: Up to 104 weeks
Percentage of Liveborn Neonates or Infants With Abnormal Hearing
Percentage of liveborn neonates or infants with abnormal hearing will be reported.
Time frame: Up to 104 weeks
Bayley Scales of Infant Development and Toddler 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 (3rd edition) 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: Week 52 and 104
Change From Baseline in Generalized Anxiety Disorder 7-Item (GAD7) Over time During Pregnancy and Postpartum
Change from baseline in GAD7 over time during pregnancy and postpartum will be reported. The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. The recall period for all items is the past 2 weeks. Responses to all items are rated on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day". The total score ranges from 0 to 21, with higher scores indicating higher severity of anxiety symptoms.
Time frame: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Change from baseline in SF-36v2 acute form domain score will be reported. The SF-36 version 2 acute is a self-administered, 36-item questionnaire measuring health-related quality of life and includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality social functioning, role limitations due to emotional problems, and mental health. The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary and a mental component summary. Responses to all items are rated on a 3, 5, or 6-point Likert scale, with higher scores indicating better health status.
Time frame: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol Five-dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Change from baseline in EQ-5D-5L visual analogue score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life. EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-VAS score ranges from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Higher score indicates good health state.
Time frame: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score
Change from baseline in EQ-5D index score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L descriptive system uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life.
Time frame: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Infant Health-Related Quality of Life Instrument (IQI) Score for Neonate or Infant Overtime
IQI score for neonate or infant will be reported. The IQI consists of 7 health attributes including sleeping, feeding, breathing, stooling or poo, mood, skin, and interaction. Responses to all items are rated on a 4-point Likert scale, with higher scores indicating better quality of life.
Time frame: Weeks 4, 8 and 52
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Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.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
Started Dec 2023 (actual). Primary completion is estimated for Aug 2027, 43 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 drug tested here: Nipocalimab
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