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Thrombocytopenia, Neonatal AlloimmunePhase 3FREESIA-3NCT06533098

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

A Phase 3 study testing Nipocalimab, Intravenous immunoglobulins (IVIG) and Prednisone in people with Thrombocytopenia, Neonatal Alloimmune, run by Janssen Research & Development, LLC at 38 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Thrombocytopenia, Neonatal Alloimmune
What is being tested?
Nipocalimab, Intravenous immunoglobulins (IVIG) and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
38 sitesin 11 countries
Study dates
10 Feb 2025to 11 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 that would preclude treatment
  • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Trial locations and contacts

38 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

38 sites in 11 countries

United States16 sites, 15 recruiting

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045

    Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Recruiting

  • Wayne State University

    Detroit, Michigan, 48201

    Recruiting

  • University of Florida at Shands

    Gainesville, Florida, 32611

    Recruiting

  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Recruiting

  • Riley Children s Hospital

    Indianapolis, Indiana, 46202

    Suspended

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Advocate Children's Hospital

    Park Ridge, Illinois, 60068

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • UC Davis School of Medicine

    Sacramento, California, 95817

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Recruiting

Other trials in United States

Germany5 sites, 5 recruiting

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

    Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

United Kingdom4 sites, 4 recruiting

  • Birmingham Women's Hospital

    Birmingham, B15 2TG

    Recruiting

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

    Liverpool, L8 7SS

    Recruiting

  • Queen Charlotte's and Chelsea Hospital

    London, W12 0HS

    Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Recruiting

Other trials in United Kingdom

Poland3 sites, 3 recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93 338

    Recruiting

  • Instytut Matki i Dziecka

    Warsaw, 01 211

    Recruiting

  • Panstwowy Instytut Medyczny MSWiA w Warszawie

    Warsaw, 02 507

    Recruiting

Other trials in Poland

Austria2 sites, 2 recruiting

  • Medizinische Universitaet Graz

    Graz, 8036

    Recruiting

  • Medical University Vienna

    Vienna, 1090

    Recruiting

Other trials in Austria

Italy2 sites, 2 recruiting

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

Other trials in Italy

Slovakia2 sites, 2 recruiting

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, 040 11

    Recruiting

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nové Zámky, 940 34

    Recruiting

Other trials in Slovakia

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Israel1 site, 1 recruiting

  • Sheba Medical Center

    Ramat Gan, 5262000

    Recruiting

Other trials in Israel

Netherlands1 site, 1 recruiting

  • Leiden University Medical Center

    Leiden, 2333 ZA

    Recruiting

Other trials in Netherlands

Slovenia1 site, 1 recruiting

  • Univerzitetni klinicni center Ljubljana

    Ljubljana, 1000

    Recruiting

Other trials in Slovenia

About this study

Official title: Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Being tested
Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone
Medical subject headings
Thrombocytopenia, Neonatal Alloimmune

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135, JNJ-86507083, M281

    Nipocalimab will be administered intravenously.

  • Intravenous immunoglobulins (IVIG)Drug

    IVIG will be administered intravenously.

  • PrednisoneDrug

    Prednisone will be administered orally.

Study groups in NCT06533098
Study groupRoleWhat they receive
Arm 1: NipocalimabExperimentalMaternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery.
Receives: Drug: Nipocalimab
Arm 2: Intravenous Immunoglobins (IVIG)ExperimentalMaternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.
Receives: Drug: Intravenous immunoglobulins (IVIG); Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L

    Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count <30*10^9/L will be reported.

    Measured: Up to 1 Week post birth

Secondary outcomes (19)

  1. Platelet Count at Birth in a Neonate

    Platelet count at birth in a neonate will be reported.

    Measured: At birth

  2. Neonate/Fetus with Outcome of Death

    Fetus/neonate with outcome of death will be reported.

    Measured: Up to 1 Week post birth

  3. Neonate with Platelet Count at Birth <10*10^9/L

    Platelet count at birth <10*10^9/L in a neonate will be reported.

    Measured: At birth

  4. Neonate with Platelet Count at Birth <30*10^9/L

    Platelet count at birth <30*10^9/L in a neonate will be reported.

    Measured: At birth

  5. Neonate with Platelet Count at Birth <50*10^9/L

    Platelet count at birth <50*10^9/L in a neonate will be reported.

    Measured: At birth

  6. Neonate with Platelet Count at Birth <150*10^9/L

    Platelet count at birth <150*10^9/L in a neonate will be reported.

    Measured: At birth

  7. Nadir Platelet Count in a Neonate

    Nadir platelet count in a neonate will be reported.

    Measured: Up to 1 Week post birth

  8. Neonate Requiring Platelet Transfusion

    Neonate who require at least one platelet transfusion will be reported.

    Measured: Up to 1 Week post birth

  9. Number of Platelet Transfusions in Neonate

    Number of platelet transfusions per neonate will be reported.

    Measured: Up to 1 Week post birth

  10. Number of Donor Exposures for Platelet Transfusions in Neonate

    Number of donor exposures for a neonate who received at least one platelet transfusion will be reported.

    Measured: Up to 1 Week post birth

  11. Neonate/Fetus With Adjudicated Bleeding

    Neonate/Fetus with adjudicated bleeding will be reported.

    Measured: Up to 1 Week post birth

  12. Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia

    Neonate requiring IVIG for the treatment of thrombocytopenia will be reported.

    Measured: Up to 1 Week post birth

  13. Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)

    Maternal participant with TEAE, SAE and AESI will be reported. An Adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.

    Measured: Up to Week 24

  14. Maternal Participant with TEAE Leading to Discontinuation of Study Intervention

    Maternal participant with TEAE leading to discontinuation of study intervention will be reported.

    Measured: Up to Week 24

  15. Neonate/Infant With TEAE, SAE and AESI

    Neonate/infant with TEAE, SAE and AESI will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.

    Measured: From Day of birth to Week 104

  16. Fetus/Neonate with a TEAE of Bleeding

    Fetus/Neonate with a TEAE of bleeding will be reported.

    Measured: From Day of birth to Week 104

  17. Neonate with a TEAE of Infection

    Neonate with a TEAE of infection will be reported.

    Measured: From Day of birth to Week 104

  18. Bayley Scales Assessment for Infant Development

    The Bayley Scales of infant development is considered the standard assessment of early child development and includes cognition, language, motor skills, social emotional, and adaptive behavior will be reported. The Bayley Scales are reference standards that measure infant and toddler development in five areas: cognition, language, motor skills, social-emotional and adaptive behavior. The cognition, language and motor skills scales are directly administered to the infant, while social-emotional, and adaptive behavior scales are caregiver questionnaires. The scores are standardized using norm reference samples with representative demographics and age adjusted for prematurity. Higher scores in the Bayley Scales indicate better outcomes.

    Measured: At Week 52 and Week 104

  19. Maternal Participants with Incidence of Antibodies to Nipocalimab

    Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.

    Measured: Up to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start10 Feb 2025
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion11 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533098
Sponsor's protocol ID
80202135FNAIT3003
Other IDs
2023-509434-19-00, 2023
Acronym
FREESIA-3
Status last verified
Nov 2026
First submitted
30 Jul 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Bussel J, Stegmann B, Baker P, Oey A, Jiang Y, Zaha R, Van Valkenburgh H, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(10):1335-1344. doi: 10.1055/a-2753-9323. Epub 2025 Nov 25.

    PubMed 41290206

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nipocalimab, Intravenous immunoglobulins (IVIG) and Prednisone in people with Thrombocytopenia, Neonatal Alloimmune, run by Janssen Research & Development, LLC at 38 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Germany, United Kingdom, Poland, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L (time frame: Up to 1 Week post birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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