Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of Nipocalimab in Pregnant Women at Risk of Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Hemolytic Disease of the Fetus and Newborn (HDFN), a condition where antibodies from the mother's blood cross the placenta and attack the developing baby's red blood cells. The research evaluates a new medication called nipocalimab, which is given through intravenous administration, comparing it to placebo. The purpose is to determine if nipocalimab can reduce the risk of fetal anemia in pregnancies where babies are at risk of developing severe HDFN.

The study involves pregnant women whose previous pregnancies were affected by severe HDFN, resulting in either the baby developing anemia, requiring blood transfusions before birth, or unfortunately losing the pregnancy. The medication or placebo will be given to participants during their pregnancy, with the treatment period lasting up to 23 weeks.

During the study, participants will receive either JNJ-80202135 (nipocalimab) as a solution for injection or infusion, or a saline solution. The study is designed so that neither the participants nor their doctors will know which treatment they are receiving. This helps ensure that the results are not influenced by expectations about the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will begin participation in the study between weeks 13 and 18 of pregnancy

    The study team will confirm the presence of specific antibodies in your blood through laboratory testing

    A non-invasive DNA test will be performed to check your baby's blood type

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either nipocalimab or a placebo (salt solution)

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be given through an intravenous infusion (directly into your vein)

  3. Step 3

    Treatment period

    You will receive regular intravenous treatments throughout your pregnancy

    The medical team will monitor your pregnancy and your baby's health regularly

    Special attention will be paid to signs of fetal anemia (low blood count in your baby)

  4. Step 4

    Monitoring and follow-up

    Regular ultrasound examinations will be performed to check your baby's development

    Blood tests will be conducted to monitor antibody levels

    The study will continue until your baby's birth

  5. Step 5

    Study completion

    The main goal is to reduce the risk of fetal anemia

    The study will assess if the treatment helps prevent serious complications related to hemolytic disease (a condition where maternal antibodies affect the baby's red blood cells)

    The entire study is expected to continue until July 2029

Who can join the trial?

7 criteria

  • Must be female, aged between 18 and 45 years old at the time of giving consent (or above 18 if required by local law)
  • Must be pregnant between 13 weeks and 0 days to 18 weeks and 6 days of pregnancy at the time of study enrollment (confirmed by ultrasound)
  • Must have a history of severe hemolytic disease in a previous pregnancy, documented by either:
    • Previous fetal anemia or fluid buildup in the fetus (called hydrops), or received blood transfusions while the baby was in the womb, OR
    • Previous loss of pregnancy or newborn death due to this condition, with specific blood antibodies above certain levels
    • Must currently have specific blood antibodies (RhD, Kell, Rhc, RhE, or RhC) above certain levels:
      • Kell antibodies must be level 4 or higher
      • Other antibodies must be level 16 or higher
      • Must have confirmation through blood testing that the current baby carries the corresponding blood type that could trigger a reaction with the mother's antibodies

Who cannot join the trial?

13 criteria

  • History of severe allergic reactions to any medications or vaccines
  • Current participation in other clinical trials or use of investigational drugs within 30 days before this study
  • Known or suspected fetal abnormalities identified during pregnancy screening
  • Multiple pregnancy (carrying more than one baby)
  • Chronic medical conditions that could affect pregnancy, such as uncontrolled diabetes or high blood pressure
  • Active infections or diseases that could impact the immune system
  • Previous pregnancy complications that resulted in adverse outcomes
  • Use of medications that could interact with the study drug
  • Blood disorders other than those related to the condition being studied
  • Inability to comply with study procedures or follow-up visits
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with providing informed consent
  • Planned relocation during the study period that would prevent completion of all visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Nipocalimab is an investigational antibody medication that works to prevent hemolytic disease of the fetus and newborn (HDFN). This medication is designed to help pregnant women who are at risk of having babies with severe anemia before birth. It works by reducing the mother's antibodies that can cross the placenta and attack the baby's red blood cells.

What is already known about the treatment

Nipocalimab - A monoclonal antibody administered through intravenous infusion, currently being investigated in Phase 3 clinical trials for the treatment of Hemolytic Disease of the Fetus and Newborn (HDFN). This medication works by reducing harmful maternal antibodies that can cross the placenta and attack the fetus's red blood cells, potentially preventing severe fetal anemia. Nipocalimab belongs to the class of immunoglobulin G (IgG) targeting therapies and represents a novel approach in managing pregnancy complications related to blood type incompatibility between mother and fetus.

Investigated diseases

Hemolytic Disease of the Fetus and Newborn (HDFN) - A blood disorder that occurs when a pregnant woman's immune system produces antibodies that attack and destroy the red blood cells of her developing baby. The condition develops during pregnancy when there is an incompatibility between the mother's and baby's blood types. This leads to the breakdown of the fetus's red blood cells, causing anemia in the developing baby. As the disease progresses, the baby may develop fluid buildup in various parts of the body. The condition can begin during pregnancy and continue after the baby is born.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502629-16-00Protocol code80202135EBF3001Estimated enrolment123 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.