← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe for pregnant women at risk for EOS-HDFN, and if it's effective, it will be measured by the percentage of participants who have a live birth at or after 32 weeks.

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.Check my eligibility

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.See study design

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

Select...

My blood test shows I am carrying a baby with a specific genetic marker.

Select...

I had a stillbirth due to complications related to HDFN.

Select...

I am a woman and at least 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates

This trial's timeline: 3 weeks for screening, Varies for treatment, and from signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Adverse Events (AEs)

Number of Participants With Live Birth at or After Gestational Age (GA) Week 32 and no Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancy

Secondary outcome measures

Gestational age at Delivery

Gestational age at First IUT

Maternal Levels of Alloantibodies

+12 more

Side effects data

From 2020 Phase 2 trial • 68 Patients • NCT03772587

21%

Rash

14%

Urinary Tract Infection

14%

Diarrhoea

14%

Oedema Peripheral

14%

Nasopharyngitis

Malaise

Asymptomatic Bacteriuria

Peripheral Swelling

Musculoskeletal Chest Pain

Vision Blurred

Vomiting

Glucose Tolerance Impaired

Eyelid Ptosis

Headache

Lymphocyte Count Decreased

Brachiocephalic Vein Thrombosis

Rash Erythematous

Herpes Zoster

Hypothyroidism

Skin Swelling

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

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

~120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,294 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

745 Previous Clinical Trials

3,959,891 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this experiment still open?

"At the moment, this trial is not seeking patients for enrollment; its last edit on clinicaltrials.gov was posted on November 22nd 2022. Thankfully, there are 35 other studies available that accept new participants at present."

Answered by AI