Hemolytic Disease of the Fetus and NewbornPhase 2NCT03842189
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
A Phase 2 study testing M281 in people with Hemolytic Disease of the Fetus and Newborn, run by Janssen Research & Development, LLC at 19 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemolytic Disease of the Fetus and Newborn
- What is being tested?
- M281
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 5 Apr 2018to 5 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approximately 15 eligible participants and their offspring will be enrolled
- Each participant must meet all of the following criteria to be enrolled in the study:
- Female and greater than or equal to (>=)18 years of age
- Pregnant to an estimated gestational age of between 8 up to 14 weeks
- A previous pregnancy with a gestation that included at least one of the following prior to week 24 gestation:
- Severe fetal anemia, defined as hemoglobin less than or equal to (<=) 0.55 multiples of the median (MOM) for gestational age
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- Fetal hydrops with peak systolic velocity MOM >=1.5
- Stillbirth with fetal or placental pathology indicative of hemolytic disease of the fetus and newborn (HDFN)
- Maternal alloantibody titers for anti-D of >=32, or anti-Kell titers >=4
- Free fetal deoxyribonucleic acid consistent with an antigen-positive fetus (blood sample taken from mother)
- Maternal evidence for Immunity to measles mumps, rubella, and varicella, as documented by serologies performed during Screening. If initial serologies are borderline or negative, they may be repeated at a second lab. Alternatively, vaccination records can be used to support evidence of immunity.
- Screening immunoglobulin G and albumin levels within the laboratory normal range for gestational age of pregnancy
- Willing to receive standard of care with intrauterine transfusion if clinically indicated
- Agree to receive recommended vaccinations per local standard of care for both mother and child throughout the course of the study
- It is recommended that patients are up-to-date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study patients who received locally-approved (and including emergency use-authorized) Coronavirus Disease 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standard of care for pregnant women receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment
Who cannot join
- Currently pregnant with multiples (twins or more)
- Pre-eclampsia In current pregnancy or history of pre-eclampsia in a previous pregnancy
- Gestational hypertension in the current pregnancy
- Current unstable hypertension
- History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy
- History of genital herpes infection
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- Active Infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior Infection or exposure, but without clinical signs and symptoms of active infection is acceptable)
- Active infection with tuberculosis as evidenced by positive QuantiFERON-tuberculosis testing
- Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted)
- Has received or is expected to receive any live virus or bacterial vaccine within 12 weeks prior to screening or has a known need to receive a live vaccine while receiving nipocalimab, or within 12 weeks after the last administration of nipocalimab in the study or has received Bacille Calmett-Guérin (BCG) vaccine within 1 year prior to the first administration of nipocalimab
- Currently receiving an antibody-based drug or an Fc-fusion protein drug
- Received plasmapheresis and/or intravenous immunoglobulin during the current pregnancy for treatment of HDFN
- COVID-19 infection: during the 6 weeks prior to baseline (regardless of vaccination status), have had any of: a) confirmed severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) (COVID-19) infection (test positive), or; b) suspected SARS-CoV-2 infection (clinical features without documented test results), or; c) close contact with a person with known or suspected SARS-CoV-2 infection. Exception: may be included with a documented negative result for a validated SARSCoV-2 test: obtained at least 2 weeks after conditions a), b), c) above (timed from resolution of key clinical features if present, example fever, cough, dyspnea) and; with absence of all conditions a), b), c) above during the period between the negative test result and the baseline study visit
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
United States8 sites
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
University of Cincinnati
Cincinnati, Ohio, 45267
University of Texas Health Science Center
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84132
University of California San Francisco
San Francisco, California, 94143
Canada3 sites
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H3T 1C5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
United Kingdom2 sites
Birmingham Children's Hospital
Birmingham, B15 2TG
University College London Hospitals NHSFT
London, WC1E 6DB
Germany1 site
Justus-Liebig-Universität Gießen, Kinderherzzentrum
Giessen, 35392
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.
- Being tested
- M281
- Keywords
- M281, Hemolytic Disease of the Fetus and Newborn, HDFN, Rhesus Disease, Hemolytic disease due to fetomaternal alloimmunization, Hemolytic disease of the newborn with Kell alloimmunization, Rhesus (Rh) isoimmunization of foetus or newborn, Isoimmunization due to other red cell factors, ABO isoimmunization of foetus or newborn, Haemolytic anaemia due to other unclassified antibodies, Isoimmune, Isoimmunized, Isoimmunization, Alloimmune, Alloimmunized, Alloimmunization, Pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M281Drug
Participants will receive once weekly intravenous (IV) infusions of M281
| Study group | Role | What they receive |
|---|---|---|
| M281 | Experimental | Not described Receives: Drug: M281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Measured: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)
Number of Neonates/Infants With Adverse Events (AEs)
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Measured: From Birth (PP Day 0) up to PP Week 96
Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab.
Measured: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Serious Adverse Events (SAEs)
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Measured: From Birth (PP Day 0) up to PP Week 96
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (>=) Grade 3 (less than [<]20 gram per liter [g/L] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Measured: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs)
Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations <200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or <300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants.
Measured: From birth (PP Day 0) up to PP Week 96
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline
Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36
Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Measured: GA Week 36
Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate
Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Measured: Baseline (GA Week 14) and GA Week 36
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin <20 g/L was from a local laboratory and was >=20 g/L when analyzed at the central laboratory for the same time point.
Measured: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).
Measured: From Birth (PP Day 0) up to PP Week 96
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline
Absolute value of vital signs - body temperature at baseline in maternal participants was reported.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36
Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.
Measured: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24
Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.
Measured: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Body Temperature
Change from baseline in vital signs- body temperature in maternal participants was reported.
Measured: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36
Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.
Measured: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.
Measured: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate
Change from baseline in vital signs- respiratory rate in maternal participants was reported.
Measured: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline
Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36
Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.
Measured: GA Week 36
Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24
Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.
Measured: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate
Change from baseline in vital signs -pulse rate in maternal participants was reported.
Measured: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36
Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.
Measured: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.
Measured: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in vital signs -SBP and DBP in maternal participants were reported.
Measured: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline
Absolute value of vital signs - body weight at baseline in maternal participants was reported.
Measured: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36
Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.
Measured: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.
Measured: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Body Weight
Change from baseline in vital signs- body weight in maternal participants was reported.
Measured: Baseline (GA Week 14), GA Week 36, and PP Week 24
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline
Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.
Measured: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1
Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.
Measured: PP Week 1
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4
Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.
Measured: PP Week 4
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24
Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.
Measured: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature
Change from baseline in vital signs- body temperature were reported for all neonates/infants.
Measured: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline
Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.
Measured: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1
Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.
Measured: PP Week 1
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4
Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.
Measured: PP Week 4
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.
Measured: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight
Change from baseline in vital signs - body weight were reported for all neonates/infants.
Measured: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.
Measured: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1
Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.
Measured: PP Week 1
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4
Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.
Measured: PP Week 4
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.
Measured: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate
Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.
Measured: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.
Measured: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1
Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.
Measured: PP Week 1
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4
Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.
Measured: PP Week 4
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.
Measured: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants.
Measured: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments
Percentage of maternal participants with intrauterine growth restriction (IUGR) based on ultrasound assessments and guidelines from American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine was reported. This outcome measure provided the incidence of with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve.
Measured: Baseline (GA Week 14), GA Weeks 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline
Percentage of maternal participants with abnormal amniotic fluid values: amniotic fluid index (AFI) at baseline was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 centimeter (cm) or >24 cm.
Measured: Baseline (GA Week 14)
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 26 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm.
Measured: GA Week 26
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 36 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm.
Measured: GA Week 36
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline
Percentage of maternal participants with abnormal amniotic fluid values: maximum vertical pocket (MVP) at baseline was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Measured: From Baseline (GA Week 14)
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 18 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Measured: GA Week 18
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 22 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Measured: GA Week 22
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score
Number of neonates/infants with Apgar score from 1 to 10 minutes of life were reported. The system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7. This is using an Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
Measured: 1, 5, and 10 minutes after birth at PP Day 0
Number of Maternal Participants With Concomitant Medications and Therapies
Number of maternal participants with concomitant medications and therapies were reported.
Measured: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Concomitant Medications and Therapies
Number of neonates/infants with concomitant medications and therapies were reported.
Measured: From birth (PP Day 0) up to PP Week 96
Percentage of Maternal Participants With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies
Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.
Measured: From baseline (GA Week 14) up to GA Week 37
Secondary outcomes (19)
Percentage of Maternal Participants With Live Birth
Percentage of maternal participants with live birth were reported.
Measured: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24
Percentage of maternal participants without an IUT before GA Week 24 were reported.
Measured: From baseline (GA Week 14) up to GA Week 24
Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT)
Gestational age (GA) at first IUT for maternal participants were reported.
Measured: From baseline (GA Week 14) up to GA Week 37
Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant
Median number of intrauterine transfusion (IUT) per maternal participants were reported.
Measured: From baseline (GA Week 14) up to GA Week 37
Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants
Frequency of intrauterine transfusions (IUTs) on maternal participants were reported. Frequency of IUTs was defined as total number of IUTs divided by the (date of delivery - date of first IUT +1)/7.
Measured: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth
Percentage of maternal participants with fetal hydrops in utero or post birth were reported.
Measured: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Maternal Participants: Gestational Age at Time of Delivery
Gestational age at time of delivery for maternal participants were reported.
Measured: From baseline (GA Week 14) up to GA Week 37
Percentage of Neonates Who Required Phototherapy
Percentage of neonates who required phototherapy were reported.
Measured: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Exchange Transfusions
Percentage of neonates who required exchange transfusions were reported.
Measured: From birth (PP Day 0) up to PP Week 24
Duration of Postnatal Phototherapy Required by Neonates
Duration of postnatal phototherapy required by neonates were reported.
Measured: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life
Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported.
Measured: From birth (PP Day 0) up to PP Week 12
Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life
Number of simple transfusions required by neonate in the first 12 weeks of life were reported.
Measured: From birth (PP Day 0) up to PP Week 12
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab
Maternal serum unoccupied neonatal concentration of Participants Fc Receptor [FcRn] receptor occupancy (RO) in Monocytes by nipocalimab were reported.
Measured: Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24
Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab
Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported.
Measured: From birth (PP Day 0) up to PP Week 24
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE
Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported.
Measured: IgG: Baseline (GA Week 14), GA Week 16, GA Week 36, birth (PP Day 0), PP Week 4, and PP Week 24; IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE: baseline (GA Week 14), GA Week 36
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE
Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE were reported in neonates/infants were reported.
Measured: Baseline (PP Day 0), PP Weeks 4, 24, 96
Serum Concentrations of Nipocalimab in Maternal Participants
Serum concentrations of Nipocalimab in maternal participants were reported.
Measured: Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants
The 45-item PedsQL infant Scales (ages 13-24 months) included physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning. Health summary score for psychosocial (sum of all items over number of items: emotional, social, cognitive functioning scales) and physical (sum of the items over number of items: physical functioning and symptoms scales), as well as a total score (sum of all items over number of items answered on all scales). Items were reverse-scored and linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). PedsQL a validated scale ranging from 0 -100, higher scores = a better quality of life.
Measured: PP Week 96
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants
The ASQ-3 assesses young child's (2-66 months) development based on age and included 6 questions in each area of child development: communication, gross motor, fine motor, problem solving, and personal-social skills. Parents answered either yes (10 points), sometimes (5 points) or not yet (0 points) to each question to complete ASQ-3 and each domain score could range from 0 to 60 points which higher score signifying stronger development.
Measured: At PP 6 month, PP 12 month, and PP 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start5 Apr 2018
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemolytic Disease of the Fetus and NewbornStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842189
- Sponsor's protocol ID
- CR108980
- Other IDs
- MOM-M281-003, 2017-004958-42, 2017
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2019
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
de Winter DP, Moise KJ Jr, Ling LE, Oepkes D, Tiblad E, Verweij EJTJ, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Debeer A, Leu JH, Nelson RM, Smith V, Schwartz LB, Tjoa ML, Komatsu Y, Saeed-Khawaja S, Lopriore E; UNITY Study Group. Paediatric outcomes after maternal nipocalimab for haemolytic disease of the fetus and newborn: an open-label, single-arm study. Arch Dis Child Fetal Neonatal Ed. 2026 Sep 7:fetalneonatal-2026-331009. doi: 10.1136/archdischild-2026-331009. Online ahead of print.
PubMed 42705868de Winter DP, Moise KJ, Ling LE, Oepkes D, Tiblad E, Joanne Verweij EJT, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Streisand JB, Bredius RGM, Cafone J, Lam E, Leu JH, Mirza A, Nelson RM, Smith V, Schwartz LB, Tjoa ML, Saeed-Khawaja S, Komatsu Y, Lopriore E. Infant Immunity after Maternal Nipocalimab in Severe Hemolytic Disease of the Fetus and Newborn. NEJM Evid. 2026 Feb;5(2):EVIDoa2500097. doi: 10.1056/EVIDoa2500097. Epub 2026 Jan 27.
PubMed 41591368Moise KJ Jr, Ling LE, Oepkes D, Tiblad E, Verweij EJTJ, Lopriore E, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Audibert F, Emery SP, Markham K, Norton ME, Ocon-Hernandez O, Pandya P, Pereira L, Silver RM, Windrim R, Streisand JB, Leu JH, Mirza A, Smith V, Schwartz LB, Tjoa ML, Saeed-Khawaja S, Komatsu Y, Bussel JB; UNITY Study Group. Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn. N Engl J Med. 2024 Aug 8;391(6):526-537. doi: 10.1056/NEJMoa2314466.
PubMed 39115062
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
- ClinicalTrials.gov ID
- NCT03842189
- Acronym / sponsor ID
- CR108980
- Keywords
- M281, Hemolytic Disease of the Fetus and Newborn, HDFN, Rhesus Disease, Hemolytic disease due to fetomaternal alloimmunization, Hemolytic disease of the newborn with Kell alloimmunization, Rhesus (Rh) isoimmunization of foetus or newborn, Isoimmunization due to other red cell factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M281 | Experimental | Drug: M281 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Approximately 15 eligible participants and their offspring will be enrolled
- Each participant must meet all of the following criteria to be enrolled in the study:
- Female and greater than or equal to (>=)18 years of age
- Pregnant to an estimated gestational age of between 8 up to 14 weeks
- A previous pregnancy with a gestation that included at least one of the following prior to week 24 gestation:
Key exclusion criteria (13 listed)
- Currently pregnant with multiples (twins or more)
- Pre-eclampsia In current pregnancy or history of pre-eclampsia in a previous pregnancy
- Gestational hypertension in the current pregnancy
- Current unstable hypertension
- History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M281Participants will receive once weekly intravenous (IV) infusions of M281 | Drug | M281 |
Primary outcome
Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Number of Neonates/Infants With Adverse Events (AEs)
Time frame: From Birth (PP Day 0) up to PP Week 96
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab.
Number of Neonates/Infants With Serious Adverse Events (SAEs)
Time frame: From Birth (PP Day 0) up to PP Week 96
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (>=) Grade 3 (less than [<]20 gram per liter [g/L] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs)
Time frame: From birth (PP Day 0) up to PP Week 96
Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations <200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or <300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants.
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36
Time frame: GA Week 36
Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate
Time frame: Baseline (GA Week 14) and GA Week 36
Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin <20 g/L was from a local laboratory and was >=20 g/L when analyzed at the central laboratory for the same time point.
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Time frame: From Birth (PP Day 0) up to PP Week 96
Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of vital signs - body temperature at baseline in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36
Time frame: GA Week 36
Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.
Maternal Participants: Change From Baseline in Vital Sign - Body Temperature
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Change from baseline in vital signs- body temperature in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36
Time frame: GA Week 36
Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.
Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Change from baseline in vital signs- respiratory rate in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36
Time frame: GA Week 36
Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.
Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Change from baseline in vital signs -pulse rate in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36
Time frame: GA Week 36
Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Change from baseline in vital signs -SBP and DBP in maternal participants were reported.
Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline
Time frame: Baseline (GA Week 14)
Absolute value of vital signs - body weight at baseline in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36
Time frame: GA Week 36
Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.
Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.
Maternal Participants: Change From Baseline in Vital Sign - Body Weight
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Change from baseline in vital signs- body weight in maternal participants was reported.
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline
Time frame: Baseline (PP Day 0)
Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1
Time frame: PP Week 1
Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4
Time frame: PP Week 4
Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24
Time frame: PP Week 24
Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Change from baseline in vital signs- body temperature were reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline
Time frame: Baseline (PP Day 0)
Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1
Time frame: PP Week 1
Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4
Time frame: PP Week 4
Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Change from baseline in vital signs - body weight were reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Time frame: Baseline (PP Day 0)
Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1
Time frame: PP Week 1
Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4
Time frame: PP Week 4
Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Time frame: Baseline (PP Day 0)
Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1
Time frame: PP Week 1
Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4
Time frame: PP Week 4
Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Time frame: PP Week 24
Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants.
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments
Time frame: Baseline (GA Week 14), GA Weeks 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36
Percentage of maternal participants with intrauterine growth restriction (IUGR) based on ultrasound assessments and guidelines from American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine was reported. This outcome measure provided the incidence of with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline
Time frame: Baseline (GA Week 14)
Percentage of maternal participants with abnormal amniotic fluid values: amniotic fluid index (AFI) at baseline was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 centimeter (cm) or >24 cm.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26
Time frame: GA Week 26
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 26 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36
Time frame: GA Week 36
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 36 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline
Time frame: From Baseline (GA Week 14)
Percentage of maternal participants with abnormal amniotic fluid values: maximum vertical pocket (MVP) at baseline was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18
Time frame: GA Week 18
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 18 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22
Time frame: GA Week 22
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 22 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm.
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score
Time frame: 1, 5, and 10 minutes after birth at PP Day 0
Number of neonates/infants with Apgar score from 1 to 10 minutes of life were reported. The system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7. This is using an Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
Number of Maternal Participants With Concomitant Medications and Therapies
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of maternal participants with concomitant medications and therapies were reported.
Number of Neonates/Infants With Concomitant Medications and Therapies
Time frame: From birth (PP Day 0) up to PP Week 96
Number of neonates/infants with concomitant medications and therapies were reported.
Percentage of Maternal Participants With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.
19 secondary outcomes
Percentage of Maternal Participants With Live Birth
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24
Time frame: From baseline (GA Week 14) up to GA Week 24
Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT)
Time frame: From baseline (GA Week 14) up to GA Week 37
Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant
Time frame: From baseline (GA Week 14) up to GA Week 37
Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Maternal Participants: Gestational Age at Time of Delivery
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Neonates Who Required Phototherapy
Time frame: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Exchange Transfusions
Time frame: From birth (PP Day 0) up to PP Week 24
Duration of Postnatal Phototherapy Required by Neonates
Time frame: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life
Time frame: From birth (PP Day 0) up to PP Week 12
Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life
Time frame: From birth (PP Day 0) up to PP Week 12
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab
Time frame: Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24
Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab
Time frame: From birth (PP Day 0) up to PP Week 24
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE
Time frame: IgG: Baseline (GA Week 14), GA Week 16, GA Week 36, birth (PP Day 0), PP Week 4, and PP Week 24; IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE: baseline (GA Week 14), GA Week 36
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE
Time frame: Baseline (PP Day 0), PP Weeks 4, 24, 96
Serum Concentrations of Nipocalimab in Maternal Participants
Time frame: Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants
Time frame: PP Week 96
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants
Time frame: At PP 6 month, PP 12 month, and PP 24 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42705868de Winter DP, Moise KJ Jr, Ling LE, Oepkes D, Tiblad E, Verweij EJTJ, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Debeer A, Leu JH, Nelson RM, Smith V, Schwartz LB, Tjoa ML, Komatsu Y, Saeed-Khawaja S, Lopriore E; UNITY Study Group. Paediatric outcomes after maternal nipocalimab for haemolytic disease of the fetus and newborn: an open-label, single-arm study. Arch Dis Child Fetal Neonatal Ed. 2026 Sep 7:fetalneonatal-2026-331009. doi: 10.1136/archdischild-2026-331009. Online ahead of print.
- Derived from this study: PubMed 41591368de Winter DP, Moise KJ, Ling LE, Oepkes D, Tiblad E, Joanne Verweij EJT, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Streisand JB, Bredius RGM, Cafone J, Lam E, Leu JH, Mirza A, Nelson RM, Smith V, Schwartz LB, Tjoa ML, Saeed-Khawaja S, Komatsu Y, Lopriore E. Infant Immunity after Maternal Nipocalimab in Severe Hemolytic Disease of the Fetus and Newborn. NEJM Evid. 2026 Feb;5(2):EVIDoa2500097. doi: 10.1056/EVIDoa2500097. Epub 2026 Jan 27.
- Derived from this study: PubMed 39115062Moise KJ Jr, Ling LE, Oepkes D, Tiblad E, Verweij EJTJ, Lopriore E, Smoleniec J, Sachs UJ, Bein G, Kilby MD, Miller RS, Devlieger R, Audibert F, Emery SP, Markham K, Norton ME, Ocon-Hernandez O, Pandya P, Pereira L, Silver RM, Windrim R, Streisand JB, Leu JH, Mirza A, Smith V, Schwartz LB, Tjoa ML, Saeed-Khawaja S, Komatsu Y, Bussel JB; UNITY Study Group. Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn. N Engl J Med. 2024 Aug 8;391(6):526-537. doi: 10.1056/NEJMoa2314466.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M281 in people with Hemolytic Disease of the Fetus and Newborn, run by Janssen Research & Development, LLC at 19 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, United Kingdom, Australia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)). The study lists 62 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842189, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.