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New drug aims to prevent deadly bleeding in unborn babies

NCT ID NCT06449651

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a medicine called nipocalimab to see if it can lower the risk of severe bleeding or death in unborn babies with a rare condition called FNAIT. The study includes 39 pregnant women who have had a previous pregnancy affected by FNAIT. Participants receive either nipocalimab or a placebo during pregnancy, and the health of the baby is monitored after birth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization * Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records * Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood * Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening * For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit Exclusion Criteria: * Currently pregnant with multiple gestations (twins or more) * History of severe preeclampsia in a previous pregnancy * History of myocardial infarction, unstable ischemic heart disease, or stroke * Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB)) * Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

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Conditions

The condition(s) this trial relates to.

fetal and neonatal alloimmune thrombocytopenia neonatal thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thrombocytopenia, neonatal alloimmune

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU Lille

    RECRUITING

    Lille, 59000, France

  • Centre Hospitalier Universitaire Vaudois CHUV

    RECRUITING

    Lausanne, 1011, Switzerland

  • Fakultna nemocnica s poliklinikou Nove Zamky

    RECRUITING

    Nové Zámky, 940 34, Slovakia

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Haukeland University Hospital

    RECRUITING

    Bergen, 5009, Norway

  • Hopital trousseau- APHP

    RECRUITING

    Paris, 75012, France

  • Hosp. Virgen Del Rocio

    COMPLETED

    Seville, 41013, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    RECRUITING

    São Paulo, 05403 000, Brazil

  • IDOR - Regional Rio de Janeiro

    RECRUITING

    Rio de Janeiro, 22281 100, Brazil

  • Instituto de Medicina Integral Professor Fernando Figueira

    RECRUITING

    Recife, 50070-902, Brazil

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Stockholm, SE-141 86, Sweden

  • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Oslo University Hospital HF Ulleval sykehus

    RECRUITING

    Oslo, 0455, Norway

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1082, Hungary

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262000, Israel

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7030, Norway

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitetssykehuset Nord-Norge HF

    RECRUITING

    Tromsø, 9019, Norway

  • Univerzitetni klinicni center Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

  • Univerzitna nemocnica L. Pasteura Kosice

    RECRUITING

    Košice, 04190, Slovakia

  • Univerzitná nemocnica Martin

    RECRUITING

    Martin, 036 01, Slovakia

More trials for these conditions

Other studies related to the condition(s) this trial covers.