RecruitingPHASE3INTERVENTIONAL

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

This research study is investigating a new medicine, nipocalimab, for pregnant individuals whose unborn babies are at high risk of a severe blood disorder called Hemolytic Disease of the Fetus and Newborn (HDFN). HDFN can cause serious anaemia in the baby before birth. The study aims to find out if nipocalimab is effective in preventing this anaemia compared to a dummy treatment (placebo). They want to see if the medicine can help more babies be born without needing urgent medical procedures while in the womb. This is a Phase 3 study, meaning it's a critical step to determine if the medicine is safe and works well enough for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

120

Start

20 Dec 2023

Estimated completion

08 Oct 2029

Hemolytic Disease of the Fetus and Newborn

What is this study about?

This study is about a condition called Hemolytic Disease of the Fetus and Newborn, often shortened to HDFN. HDFN happens when a pregnant person's immune system, which normally fights off infections, starts to attack the baby's red blood cells. Red blood cells are really important because they carry oxygen around the body. If too many of the baby's red blood cells are destroyed, the baby can become anaemic, meaning they don't have enough oxygen in their blood. In severe cases, this can be very serious for the baby's health.

The study is testing a new medicine called nipocalimab. Scientists believe nipocalimab might be able to stop the pregnant person's immune system from attacking the baby's red blood cells. Half of the participants will receive nipocalimab, and the other half will receive a 'placebo', which looks like the medicine but contains no active ingredients. This allows researchers to compare whether nipocalimab is truly making a difference in preventing anaemia in the baby.

The main goal is to see if babies born to mothers who received nipocalimab are less likely to have severe anaemia compared to those whose mothers received the placebo. This could potentially reduce the need for difficult medical treatments during pregnancy. It’s important to remember that this is a research study, and we are still learning about how nipocalimab works and its full effects.

Key takeaways

This study is for pregnant individuals at risk of their baby developing severe anaemia due to HDFN.
It's testing a new medicine, nipocalimab, against a placebo (dummy medicine).
The main goal is to see if nipocalimab can prevent severe anaemia in the baby before birth.
Participation involves regular clinic visits, blood tests, and scans.
You won't know if you're receiving the active medicine or the placebo.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you need to be pregnant and between 13 and 18 weeks into your pregnancy when you join. You must also have a history of a severe form of HDFN in a previous pregnancy. This means that a previous baby had severe anaemia, fluid build-up (hydrops), or needed blood transfusions while in the womb, or sadly, there was a fetal loss or newborn death due to HDFN.

For your current pregnancy, blood tests must show that your immune system is making specific antibodies (RhD, Kell, Rhc, RhE, or RhC) at levels that are known to cause problems. We would also need to confirm that your baby has the specific blood factor that your immune system is reacting against using a special blood test from your own blood. You'll also need to be generally healthy, as confirmed by a physical exam and some basic medical tests.

There are some reasons you wouldn't be able to join. For example, if you are pregnant with twins or more, or if your baby already shows signs of anaemia in this current pregnancy before the study starts. Also, if you’ve had severe pre-eclampsia (a type of high blood pressure in pregnancy) before 34 weeks in a previous pregnancy or if your baby grew very slowly in a previous pregnancy.

Quick self-check

Are you currently pregnant and between 13 and 18 weeks gestation?
Have you had a previous pregnancy where the baby suffered from severe HDFN (e.g., severe anaemia, needed transfusions in the womb, or sadly, fetal loss due to HDFN)?
Do your current blood tests show specific antibodies at high levels that could cause HDFN?
Is your baby confirmed to have the blood factor that your immune system is reacting to?
Are you generally healthy enough to participate in a clinical study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will either receive the study medicine, nipocalimab, or a placebo (a dummy medicine). You won’t know which one you are receiving. The study involves regular visits to the clinic for check-ups, blood tests, and scans to monitor your baby's health and your own. You will continue with these visits and treatments throughout your pregnancy up until the birth of your baby.

After your baby is born, there will be some follow-up appointments for you and your baby to check on everyone's health. The total time you would be involved in the study, including follow-up after birth, would be several months. All tests, medicines, and medical care directly related to the study will be provided at no cost, and you would be supported throughout by a dedicated study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. A potential benefit could be that nipocalimab might help prevent serious anaemia in your baby, potentially reducing the need for difficult medical procedures during pregnancy. However, since this is a new medicine, we don't yet know all its effects, and it's possible it might not work or could have side effects. You might experience discomfort from blood tests or other procedures, and there's always a chance of unknown risks. You will be closely monitored throughout the study for any health changes. It's very important to remember that joining is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (61)

University of California at San Diego
La Jolla, United States· Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, United States· Recruiting
UC Davis School of Medicine
Sacramento, United States· Recruiting
Childrens Hospital Colorado
Aurora, United States· Recruiting
University of Miami
Miami, United States· Recruiting
Advocate Children's Hospital
Park Ridge, United States· Recruiting
Riley Children s Hospital
Indianapolis, United States· Recruiting
University of Kentucky Medical Center
Lexington, United States· Recruiting
Johns Hopkins Hospital
Baltimore, United States· Recruiting
Midwest Fetal Care Center
Minneapolis, United States· Recruiting
Columbia University Medical Center
New York, United States· Recruiting
University of North Carolina (UNC) - School of Medicine
Chapel Hill, United States· Recruiting

+49 more sites — see the official record for the full list.

Common questions

What is HDFN?

HDFN (Hemolytic Disease of the Fetus and Newborn) is a condition where a pregnant person's immune system attacks their baby's red blood cells, which can lead to anaemia in the baby.

What is nipocalimab?

Nipocalimab is a new medicine being tested in this study to see if it can stop the immune system from attacking the baby's red blood cells and prevent anaemia.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the active medicine.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving nipocalimab or the placebo until the study is over.

What happens after my baby is born?

You and your baby will have follow-up appointments after birth to check on both of your health and any long-term effects of the study medicine.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.