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Monoclonal Antibodies

M281 for Hemolytic Disease of the Fetus and Newborn

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Free fetal deoxyribonucleic acid consistent with an antigen-positive fetus (blood sample taken from mother)
Stillbirth with fetal or placental pathology indicative of hemolytic disease of the fetus and newborn (HDFN)
Must not have
History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy
Active infection with tuberculosis as evidenced by positive QuantiFERON-tuberculosis testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 weeks post birth
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called M281 to see if it is safe for pregnant women and their babies. It focuses on women at high risk for a serious blood condition in their babies. The goal is to prevent the need for blood transfusions before birth and ensure healthy births.

Who is the study for?
This trial is for pregnant women at least 18 years old, between 8-14 weeks gestation, who have a high risk of severe HDFN due to previous pregnancy complications or specific maternal alloantibody titers. Participants must be willing to receive standard care including intrauterine transfusions if needed and agree to recommended vaccinations.
What is being tested?
The study tests the safety and effectiveness of M281 in preventing Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). Success is measured by live births after week 32 without needing an intrauterine transfusion during pregnancy.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions at the injection site, allergic responses, or other immune-related effects given that M281 is an investigational drug targeting immune pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood test shows I am carrying a baby with a specific genetic marker.
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I had a stillbirth due to complications related to HDFN.
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I am a woman and at least 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had severe bladder infections or more than 4 UTIs in the last year.
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I have an active tuberculosis infection confirmed by a test.
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My blood pressure is not well-controlled.
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I have had genital herpes.
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I am currently on a treatment that involves antibody drugs.
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I have received treatments for HDFN during my current pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 weeks post birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 weeks post birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of Participants With Fetal Hydrops

Side effects data

From 2020 Phase 2 trial • 68 Patients • NCT03772587
21%
Rash
14%
Urinary Tract Infection
14%
Diarrhoea
14%
Oedema Peripheral
14%
Nasopharyngitis
7%
Glucose Tolerance Impaired
7%
Musculoskeletal Chest Pain
7%
Hypothyroidism
7%
Eyelid Ptosis
7%
Vision Blurred
7%
Vomiting
7%
Malaise
7%
Peripheral Swelling
7%
Asymptomatic Bacteriuria
7%
Herpes Zoster
7%
Lymphocyte Count Decreased
7%
Headache
7%
Rash Erythematous
7%
Skin Swelling
7%
Brachiocephalic Vein Thrombosis
7%
Thrombocytopenia
7%
Abdominal Pain Upper
7%
Nausea
7%
Vessel Puncture Site Pruritus
7%
Vessel Puncture Site Swelling
7%
Cellulitis
7%
Conjunctivitis
7%
Blood Pressure Increased
7%
Neutrophil Percentage Increased
7%
Hypophosphataemia
7%
Back Pain
7%
Muscle Spasms
7%
Muscle Twitching
7%
Cough
7%
Dysphonia
7%
Erythema
7%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nipocalimab 60 mg/kg (Q2W)
Placebo
Nipocalimab 5 Milligrams/Kilogram (mg/kg)
Nipocalimab 30 mg/kg
Nipocalimab 60 mg/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: M281Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M281
2016
Completed Phase 2
~140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hemolytic Disease of the Fetus and Newborn (HDFN) include Anti-FcRn monoclonal antibodies like M281. These treatments target the neonatal Fc receptor (FcRn), which is responsible for extending the half-life of IgG antibodies. By inhibiting FcRn, these treatments lower the levels of harmful IgG antibodies that can cross the placenta and cause fetal red blood cell destruction. This mechanism is vital for HDFN patients as it helps to prevent severe hemolysis, reducing the need for invasive procedures such as intrauterine transfusions and improving overall pregnancy outcomes.
Treatment for Fisher syndrome, Bickerstaff's brainstem encephalitis and related disorders.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,889 Total Patients Enrolled
1 Trials studying Hemolytic Disease of the Fetus and Newborn
120 Patients Enrolled for Hemolytic Disease of the Fetus and Newborn
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,916 Total Patients Enrolled
1 Trials studying Hemolytic Disease of the Fetus and Newborn
120 Patients Enrolled for Hemolytic Disease of the Fetus and Newborn

Media Library

M281 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03842189 — Phase 2
Hemolytic Disease of the Fetus and Newborn Research Study Groups: M281
Hemolytic Disease of the Fetus and Newborn Clinical Trial 2023: M281 Highlights & Side Effects. Trial Name: NCT03842189 — Phase 2
M281 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842189 — Phase 2
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