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 ID: NCT03842189
Last Updated: 2026-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2018-04-05
2024-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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M281
M281
Participants will receive once weekly intravenous (IV) infusions of M281
Interventions
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M281
Participants will receive once weekly intravenous (IV) infusions of M281
Eligibility Criteria
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Inclusion Criteria
* 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 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
Exclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of California San Francisco
San Francisco, California, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Liverpool Hospital
Sydney, , Australia
Universitair Ziekenhuis Leuven
Leuven, , Belgium
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Justus-Liebig-Universität Gießen, Kinderherzzentrum
Giessen, , Germany
Leiden University Medical Center
Leiden, , Netherlands
Hosp. Univ. San Cecilio
Granada, , Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Birmingham Children's Hospital
Birmingham, , United Kingdom
University College London Hospitals NHSFT
London, , United Kingdom
Countries
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References
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de 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.
Moise 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MOM-M281-003
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004958-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108980
Identifier Type: -
Identifier Source: org_study_id
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