What side effects are associated with this type of intervention?

Treatments for Hemolytic Disease of the Fetus and Newborn (HDFN) such as intravenous immunoglobulin (IVIG) and intrauterine transfusions have known side effects. IVIG can cause headaches, migraines, fever, chills, and fatigue. Intrauterine transfusions carry risks including preterm labor, infection, and fetal distress. Monoclonal antibodies like M281, which are still under investigation, may cause infusion reactions such as fever, chills, rash, and potential immunosuppression, leading to an increased risk of infections.

What prior FDA approvals exist?

Historically, the FDA has approved treatments for Hemolytic Disease of the Fetus and Newborn (HDFN) that include Rh immunoglobulin (RhIg) products, such as Rho(D) immune globulin, which prevent Rh sensitization in Rh-negative mothers. These treatments are different from the investigational drug M281, an Anti-FcRn Monoclonal Antibody, which is being studied for its potential to treat HDFN by modulating the immune response. Currently, there are no FDA-approved Anti-FcRn Monoclonal Antibodies specifically for HDFN, making M281 a novel approach in this therapeutic area.

What other types of research exist?

Promising alternatives to M281 for treating Hemolytic Disease of the Fetus and Newborn (HDFN) include other monoclonal antibodies such as rituximab, which has been used in various immune-mediated conditions. Additionally, therapies like mycophenolate mofetil (MMF) and intravenous immunoglobulin (IVIG) could be considered, although they are not first-line treatments. These alternatives target the immune system and have shown efficacy in related conditions, making them potential options for HDFN treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 weeks post birth

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

Glucose Tolerance Impaired

Musculoskeletal Chest Pain

Hypothyroidism

Eyelid Ptosis

Vision Blurred

Vomiting

Malaise

Peripheral Swelling

Asymptomatic Bacteriuria

Herpes Zoster

Lymphocyte Count Decreased

Headache

Rash Erythematous

Skin Swelling

Brachiocephalic Vein Thrombosis

Thrombocytopenia

Abdominal Pain Upper

Nausea

Vessel Puncture Site Pruritus

Vessel Puncture Site Swelling

Cellulitis

Conjunctivitis

Blood Pressure Increased

Neutrophil Percentage Increased

Hypophosphataemia

Back Pain

Muscle Spasms

Muscle Twitching

Cough

Dysphonia

Erythema

Pruritus

100%

80%

60%

40%

20%

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

0 / 9Eligibility criteria met

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.