CompletedPhase 2

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)

United States25 participantsStarted 2018-04-05

Plain-language 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). 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 mot…

What they're measuring

Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: 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)

Timeframe: From Birth (PP Day 0) up to PP Week 96

Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: 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)

Timeframe: From Birth (PP Day 0) up to PP Week 96

Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)

Timeframe: 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)

Timeframe: From birth (PP Day 0) up to PP Week 96

Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline

Timeframe: Baseline (GA Week 14)

Trial details

NCT IDNCT03842189

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-05

Results submitted2025-07-22

View on ClinicalTrials.gov More Hemolytic Disease of the Fetus and Newborn trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: 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)

Timeframe: From Birth (PP Day 0) up to PP Week 96

Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: 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)

Timeframe: From Birth (PP Day 0) up to PP Week 96

Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)

Timeframe: 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)

Timeframe: From birth (PP Day 0) up to PP Week 96

Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline

Timeframe: Baseline (GA Week 14)