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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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had severe bladder infections or more than 4 UTIs in the last year.
Select...
I have an active tuberculosis infection confirmed by a test.
Select...
My blood pressure is not well-controlled.
Select...
I have had genital herpes.
Select...
I am currently on a treatment that involves antibody drugs.
Select...
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
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 • NCT0377258721%
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need corticosteroids or immunosuppressants for a condition not related to pregnancy.My blood test shows I am carrying a baby with a specific genetic marker.I have had severe bladder infections or more than 4 UTIs in the last year.I had a stillbirth due to complications related to HDFN.I haven't had any live vaccines recently and don't plan to while on nipocalimab.I have proof of immunity to measles, mumps, rubella, and chickenpox, either through blood tests or vaccination records.I have an active tuberculosis infection confirmed by a test.I have not had COVID-19 or been in close contact with someone who has, in the last 6 weeks.My blood pressure is not well-controlled.I have had genital herpes.I do not currently have an active infection like syphilis or herpes.I am currently on a treatment that involves antibody drugs.I have received treatments for HDFN during my current pregnancy.I am a woman and at least 18 years old.I am willing to undergo a blood transfusion into the womb if needed.I am up-to-date with my vaccinations, including COVID-19, as per local guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: M281
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.