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)
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ClinicalTrials.gov Identifier: NCT03842189 |
Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemolytic Disease of the Fetus and Newborn | Drug: M281 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | July 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: M281 |
Drug: M281
Participants will receive once weekly intravenous (IV) infusions of M281 |
- Number of Participants With Adverse Events (AEs) [ Time Frame: From signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates ]
- Number of Participants With Live Birth at or After Gestational Age (GA) Week 32 and no Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancy [ Time Frame: Up to approximately GA Week 37 ]
- Global Clinical Outcome (GCO) Rank Score (GCO Rank) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
- Number of Participants With GCO Clinically Meaningful Classification (GCO Class) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
- Number of Participants With live Birth [ Time Frame: Up to approximately GA Week 37 ]
- Number of Participants at GA Week 24 Without an IUT [ Time Frame: GA Week 24 ]
- Gestational age at First IUT [ Time Frame: Up to approximately GA Week 37 ]
- Number of IUTs Required [ Time Frame: Up to approximately GA Week 37 ]
- Gestational age at Delivery [ Time Frame: Up to approximately GA Week 37 ]
- Number of Participants With Fetal Hydrops [ Time Frame: Up to approximately 24 weeks post birth ]Fetal hydrops is severe edema in the skin and serous cavities of the neonate.
- Number of Neonates Requiring Phototherapy [ Time Frame: Up to approximately 24 weeks post birth ]
- Number of Neonates Requiring Exchange transfusions [ Time Frame: Up to approximately 24 weeks post birth ]
- Number of Days of Postnatal Phototherapy Required by Neonate [ Time Frame: Up to approximately 24 weeks post birth ]
- Number of Neonates Requiring Simple Transfusions in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
- Number of Simple Transfusions Required by Neonate in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
- Percentage of Maternal Fc Receptor (FcRn) Receptor Occupancy (RO) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
- Maternal Levels of Total Immunoglobulin G (IgG) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
- Maternal Levels of Alloantibodies [ Time Frame: GA Week 14 to approximately GA Week 36 ]
- Mean Concentration of M281 in Maternal Participants [ Time Frame: GA Week 14 to approximately GA Week 36 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 ≥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 ≤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)
- MaternaI 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
Exclusion Criteria:
- 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
- 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)
- Received live vaccine within 3 months prior to first intravenous infusion 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842189
Contact: Momenta General Queries | +1 617-491-9700 | ClinicalTrialInfo@momentapharma.com |
United States, New York | |
Momenta Investigational Site | Recruiting |
New York, New York, United States, 10032 | |
United States, Ohio | |
Momenta Investigational Site | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
United States, Oregon | |
Momenta Investigational Site | Recruiting |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Momenta Investigational Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
Momenta Investigational Site | Withdrawn |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Momenta Investigational Site | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Australia, New South Wales | |
Momenta Investigational Site | Recruiting |
Sydney, New South Wales, Australia, 2170 | |
Belgium | |
Momenta Investigational Site | Recruiting |
Leuven, Flemish Brabant, Belgium, 3000 | |
Canada, British Columbia | |
Momenta Investigational Site | Suspended |
Vancouver, British Columbia, Canada, V6H 3N1 | |
Canada, Ontario | |
Momenta Investigational Site | Recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Canada, Quebec City | |
Momenta Investigational Site | Not yet recruiting |
Montréal, Quebec City, Canada, H3T 1C5 | |
Germany | |
Momenta Investigational Site | Recruiting |
Giessen, Hessen, Germany, 35392 | |
Netherlands | |
Momenta Investigational Site | Recruiting |
Leiden, Zuid-Holland, Netherlands, 2333 ZA | |
Spain | |
Momenta Investigational Site | Recruiting |
Granada, Spain, 18012 | |
Sweden | |
Momenta Investigational Site | Recruiting |
Stockholm, Sweden, SE-141 86 | |
United Kingdom | |
Momenta Investigational Site | Recruiting |
Birmingham, England, United Kingdom, B15 2TG | |
Momenta Investigational Site | Recruiting |
London, England, United Kingdom, NW1 2BU |
Study Director: | Momenta General Queries | Momenta Pharmaceuticals, Inc. |
Responsible Party: | Momenta Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03842189 |
Other Study ID Numbers: |
MOM-M281-003 2017-004958-42 ( EudraCT Number ) |
First Posted: | February 15, 2019 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Hemolysis Pathologic Processes |