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New drug could protect unborn babies from dangerous bleeding disorder

NCT ID NCT06533098

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 times

Summary

This study tests whether a drug called nipocalimab can prevent severe bleeding in unborn babies at risk of FNAIT, a condition where the mother's immune system attacks the baby's platelets. About 50 pregnant women with a history of FNAIT will receive either nipocalimab or standard IVIG treatment. The goal is to see if nipocalimab better protects the baby from death, severe bleeding, or very low platelet counts.

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 50 people

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

Started

Feb 2025

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) from week 13\* to 18 at visit 1 \*Randomization for high-risk FNAIT participants to occur at GA Week 12 * Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk) * Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal 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, to IVIG or to prednisone * 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

    28 sites in 7 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

  • Advocate Children's Hospital

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Birmingham Women's Hospital

    RECRUITING

    Birmingham, B15 2TG, United Kingdom

  • Childrens Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Instytut Centrum Zdrowia Matki Polki

    RECRUITING

    Lodz, 93 338, Poland

  • Instytut Matki i Dziecka

    RECRUITING

    Warsaw, 01 211, Poland

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Leiden University Medical Center

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital

    RECRUITING

    Liverpool, L8 7SS, United Kingdom

  • Medical University Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Medizinische Universitaet Graz

    RECRUITING

    Graz, 8036, Austria

  • Oregon Health And Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Panstwowy Instytut Medyczny MSWiA w Warszawie

    RECRUITING

    Warsaw, 02 507, Poland

  • Queen Charlotte's and Chelsea Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • Riley Children s Hospital

    SUSPENDED

    Indianapolis, Indiana, 46202, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262000, Israel

  • The University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • UC Davis School of Medicine

    RECRUITING

    Sacramento, California, 95817, United States

  • Universitaetsklinikum Giessen und Marburg GmbH

    RECRUITING

    Giessen, 35392, Germany

  • Universitaetsklinikum Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitatsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospital and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

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