A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06449651 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 80202135FNAIT30012023-504307-88-00
• Study Type: interventional
• Target: 39
• Locations: 11 countries
• Sites: 18

Brief Summary

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Conditions

Thrombocytopenia, Neonatal Alloimmune

Outcome Measures

Primary Outcomes (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.

  Up to 1 week post birth

Secondary Outcomes (24)

• Neonate/Fetus With Adjudicated Bleeding

  Up to 1 Week post birth

• Platelet Count at Birth in a Neonate

  At birth

• Neonate/Fetus with Outcome of Death

  Up to 1 Week post birth

• Platelet Count at Birth <10×10^9/L in a Neonate

  At birth

• Platelet Count at Birth <30×10^9/ L In a Neonate

  At birth

Study Arms (2)

Nipocalimab

ACTIVE COMPARATOR

Maternal participants will receive nipocalimab Intravenously (IV).

Drug: Nipocalimab

Placebo

PLACEBO COMPARATOR

Maternal participants will receive placebo IV.

Drug: Placebo

Interventions

Nipocalimab DRUG

Nipocalimab will be administered intravenously.

Also known as: JNJ-80202135, JNJ-86507083

Nipocalimab

Placebo DRUG

Placebo will be administered intravenously.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (21)

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira

Recife, 50070-902, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, 22281 00, Brazil

RECRUITING

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403 000, Brazil

RECRUITING

CHRU Lille

Lille, 59000, France

RECRUITING

Hopital trousseau- APHP

Paris, 75012, France

RECRUITING

Semmelweis Egyetem

Budapest, 1082, Hungary

RECRUITING

Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Haukeland University Hospital

Bergen, 5009, Norway

RECRUITING

Oslo University Hospital HF Ulleval sykehus

Oslo, 0455, Norway

RECRUITING

Universitetssykehuset Nord-Norge HF

Tromsø, 9019, Norway

RECRUITING

St. Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

Univerzitna nemocnica L. Pasteura Kosice

Košice, 04190, Slovakia

RECRUITING

Univerzitná nemocnica Martin

Martin, 036 01, Slovakia

RECRUITING

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, 940 34, Slovakia

RECRUITING

Univerzitetni klinicni center Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Hosp. Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Karolinska Universitetssjukhuset Huddinge

Stockholm, SE-141 86, Sweden

RECRUITING

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (1)

• Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28.

  PMID: 40720970 DERIVED

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 5, 2029
• Study Completion (Estimated): December 5, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1); IL (1); IT (2); ES (1); FR (2); SL (1); HU (1); NO (4); BE (1); BR (3); CH (1)