Recruiting

Phase 3

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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06533098

Conditions

Thrombocytopenia, Neonatal Alloimmune

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Intravenous immunoglobulins (IVIG)

Prednisone

Study Details

Brief 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).

Conditions

Thrombocytopenia, Neonatal Alloimmune

Study ID

NCT06533098

Start date

Feb 10, 2025

Status verified date

Aug, 2026

Completion date

Dec 11, 2029

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Nipocalimab

Maternal 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.

experimental: Arm 2: Intravenous Immunoglobins (IVIG)

Maternal 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.

Interventions

Nipocalimab

Nipocalimab will be administered intravenously.

Intravenous immunoglobulins (IVIG)

IVIG will be administered intravenously.

Prednisone

Prednisone will be administered orally.

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 ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

UC Davis School of Medicine

Recruiting

Sacramento, California, United States, 95817

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Advocate Children's Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.