Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M281 · 4 trials · 4 indications
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.
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.
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.
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 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 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.
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.
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.
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.
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.
Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).
Absolute value of vital signs - body temperature at baseline in maternal participants was reported.
Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.
Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.
Change from baseline in vital signs- body temperature in maternal participants was reported.
Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.
Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.
Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.
Change from baseline in vital signs- respiratory rate in maternal participants was reported.
Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.
Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.
Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.
Change from baseline in vital signs -pulse rate in maternal participants was reported.
Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.
Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.
Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.
Change from baseline in vital signs -SBP and DBP in maternal participants were reported.
Absolute value of vital signs - body weight at baseline in maternal participants was reported.
Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.
Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.
Change from baseline in vital signs- body weight in maternal participants was reported.
Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.
Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.
Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.
Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.
Change from baseline in vital signs- body temperature were reported for all neonates/infants.
Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.
Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.
Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.
Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.
Change from baseline in vital signs - body weight were reported for all neonates/infants.
Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.
Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.
Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.
Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.
Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.
Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.
Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.
Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.
Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.
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 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 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 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 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 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 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 was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
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 were reported.
Number of neonates/infants with concomitant medications and therapies were reported.
Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.
| Arm | Type | Description |
|---|---|---|
| M281 administered every 4 weeks (double-blind period) | EXPERIMENTAL | Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period. |
| M281 administered every 2 weeks (double-blind period) | EXPERIMENTAL | Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period. |
| Placebo administered every 2 weeks (double-blind period) | EXPERIMENTAL | Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period. |
| M281 administered every 4 weeks (open-label extension period) | EXPERIMENTAL | Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period. |
| M281 administered every 2 weeks (open-label extension period) | EXPERIMENTAL | Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period. |
| M281 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M281 | DRUG | M281 administered as IV infusion |
| Placebo | OTHER | Placebo administered as intravenous (IV) infusion |
Inclusion criteria: * Participants greater than or equal to (\>=)18 years of age * Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants a...
M281 is an investigational drug being studied for several conditions, including generalized myasthenia gravis, hemolytic disease of the fetus and newborn, and warm autoimmune hemolytic anemia. It has also been evaluated in healthy volunteers to assess its safety and tolerability.
M281 targets the neonatal Fc receptor (FcRn), a protein involved in antibody recycling. By blocking FcRn, M281 is designed to reduce levels of pathogenic IgG antibodies, which may be relevant in autoimmune conditions. This mechanism is being explored in clinical trials for diseases like generalized myasthenia gravis.
M281 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications, including neurological and autoimmune conditions.
M281 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in healthy volunteers, generalized myasthenia gravis, and hemolytic disease of the fetus and newborn. A Phase 2 trial in warm autoimmune hemolytic anemia is active but not recruiting participants.
M281 has been studied in several clinical trials. NCT02828046 was a Phase 1 dose-escalation study in healthy volunteers. NCT03772587 evaluated M281 in adults with generalized myasthenia gravis. NCT03842189 studied M281 in pregnant women at risk for hemolytic disease of the fetus and newborn. NCT04119050 is an ongoing Phase 2 trial in warm autoimmune hemolytic anemia.
M281 is also known as nipocalimab. The drug has been referred to by both names in clinical research and development contexts. It is an investigational FcRn blocker being developed by Johnson & Johnson for multiple autoimmune and alloimmune conditions.