Trial · NCT03842189
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)
NCT03842189, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2026-01-28
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. 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). Trials, record NCT03842189. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03842189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT03842189
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hemolytic Disease of the Fetus and Newborn
- Interventions
- M281
- First posted
- 2019-02-15
- Last updated
- 2026-03-25
- Other registries' IDs
- eudract:2017-004958-42
- Results first posted
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes81
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | 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. |
| Primary | Number of Neonates/Infants With Adverse Events (AEs) | 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. |
| Primary | Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 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. |
| Primary | Number of Neonates/Infants With Serious Adverse Events (SAEs) | 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. |
| Primary | Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) | 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. |
| Primary | Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) | 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. |
| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | 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. |
| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | 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. |
| Primary | Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | 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. |
| Primary | Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | 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. |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 registered outcomesOutcomes81
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Adverse Events (AEs) | From Birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Serious Adverse Events (SAEs) | From Birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) | From birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | Baseline (GA Week 14) | The full analysis set (FAS) included all maternal participants who received any dose of nipocalimab. | Beats per minute | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Beats per minute | MEAN |
| PRIMARY | Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | Baseline (GA Week 14) and GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Beats per minute | MEAN |
| PRIMARY | Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | The safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. Here, n (number analyzed): number of participants evaluable for each category. n=0 signifies no participant was available for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 outcomesResults by group948
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | Group 1 (Maternal): 30 mg/kg BLW | 3 | Participants | ||
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | Group 2 (Maternal): 30 to 45 mg/kg BLW | 2 | Participants | ||
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | Group 3 (Maternal): 45 mg/kg BLW | 4 | Participants | ||
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | Group 4 (Maternal): 45 mg/kgTAW | 4 | Participants | ||
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | All Maternal Participants | 13 | Participants | ||
| Number of Neonates/Infants With Adverse Events (AEs) | Group 1 (Neonates and Infants): 30 mg/kg BLW | 3 | Participants | ||
| Number of Neonates/Infants With Adverse Events (AEs) | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | 2 | Participants | ||
| Number of Neonates/Infants With Adverse Events (AEs) | Group 3 (Neonates and Infants): 45 mg/kg BLW | 4 | Participants | ||
| Number of Neonates/Infants With Adverse Events (AEs) | Group 4 (Neonates and Infants): 45 mg/kg TAW | 3 | Participants | ||
| Number of Neonates/Infants With Adverse Events (AEs) | All Neonates and Infants | 12 | Participants |
1 to 10 of 948Source ClinicalTrials.gov
See all 948 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Maternal): 30 mg/kg BLW | 3 | |
| Overall Study | STARTED | Group 2 (Maternal): 30 to 45 mg/kg BLW | 2 | |
| Overall Study | STARTED | Group 3 (Maternal): 45 mg/kg BLW | 4 | |
| Overall Study | STARTED | Group 4 (Maternal): 45 mg/kg TAW | 4 | |
| Overall Study | STARTED | Group 1 (Neonates and Infants): 30 mg/kg BLW | 3 | |
| Overall Study | STARTED | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | 2 | |
| Overall Study | STARTED | Group 3 (Neonates and Infants): 45 mg/kg BLW | 4 | |
| Overall Study | STARTED | Group 4 (Neonates and Infants): 45 mg/kg TAW | 3 | |
| Overall Study | COMPLETED | Group 1 (Maternal): 30 mg/kg BLW | 3 | |
| Overall Study | COMPLETED | Group 2 (Maternal): 30 to 45 mg/kg BLW | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events992
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Group 1 (Maternal): 30mg/kg BLW | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 (Maternal): 30 to45 mg/kg BLW | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 3 (Maternal): 45mg/kg BLW | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 4 (Maternal): 45mg/kg TAW | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 (Neonates and Infants): 30 mg/kg BLW | 3 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 3 (Neonates and Infants): 45 mg/kg BLW | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 4 (Neonates and Infants): 45 mg/kg TAW | 0 | 3 | |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Group 1 (Maternal): 30mg/kg BLW | 0 | 3 | |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Group 2 (Maternal): 30 to45 mg/kg BLW | 0 | 2 |
1 to 10 of 992Source ClinicalTrials.gov
See all 992 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (Maternal): 30mg/kg BLW | 0 | 3 |
| Total, all-cause mortality | Group 2 (Maternal): 30 to45 mg/kg BLW | 0 | 2 |
| Total, all-cause mortality | Group 3 (Maternal): 45mg/kg BLW | 0 | 4 |
| Total, all-cause mortality | Group 4 (Maternal): 45mg/kg TAW | 0 | 4 |
| Total, all-cause mortality | Group 1 (Neonates and Infants): 30 mg/kg BLW | 0 | 3 |
| Total, all-cause mortality | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | 0 | 2 |
| Total, all-cause mortality | Group 3 (Neonates and Infants): 45 mg/kg BLW | 0 | 4 |
| Total, all-cause mortality | Group 4 (Neonates and Infants): 45 mg/kg TAW | 0 | 3 |
| Total, other adverse events | Group 1 (Maternal): 30mg/kg BLW | 3 | 3 |
| Total, other adverse events | Group 2 (Maternal): 30 to45 mg/kg BLW | 2 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03842189
GET https://conductscience.org/api/trials/v1/NCT03842189/registered?page=2