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

Phase 3RecruitingNCT06533098

Janssen Research & Development, LLC50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thrombocytopenia, Neonatal Alloimmune

Interventions

NipocalimabDRUG

Nipocalimab will be administered intravenously.

Intravenous immunoglobulins (IVIG)DRUG

IVIG will be administered intravenously.

PrednisoneDRUG

Prednisone will be administered orally.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant and an estimated gestational age from week 13 to 18 at visit 1 * 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

Locations (21)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 Week post birth

Secondary Outcomes

Platelet Count at Birth in a Neonate

Platelet count at birth in a neonate will be reported.

Time frame: At birth

Neonate/Fetus with Outcome of Death

Fetus/neonate with outcome of death will be reported.

Time frame: Up to 1 Week post birth

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

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

Time frame: At birth

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

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

Time frame: At birth

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

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

Time frame: At birth

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

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

Time frame: At birth

Nadir Platelet Count in a Neonate

Nadir platelet count in a neonate will be reported.

Central Contacts

Study Contact

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UC Davis School of Medicine

Sacramento, California, United States

RECRUITING

Childrens Hospital Colorado

Aurora, Colorado, United States

RECRUITING

Advocate Children's Hospital

Park Ridge, Illinois, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

RECRUITING

Medizinische Universitaet Graz

Graz, Austria

RECRUITING

Medical University Vienna

Vienna, Austria

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

RECRUITING

...and 11 more locations

Time frame: Up to 1 Week post birth

Neonate Requiring Platelet Transfusion

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

Time frame: Up to 1 Week post birth

Number of Platelet Transfusions in Neonate

Number of platelet transfusions per neonate will be reported.

Time frame: Up to 1 Week post birth

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.

Time frame: Up to 1 Week post birth

Neonate/Fetus With Adjudicated Bleeding

Neonate/Fetus with adjudicated bleeding will be reported.

Time frame: Up to 1 Week post birth

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

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

Time frame: Up to 1 Week post birth

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.

Time frame: Up to Week 24

Maternal Participant with TEAE Leading to Discontinuation of Study Intervention

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

Time frame: Up to Week 24

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.

Time frame: From Day of birth to Week 104

Fetus/Neonate with a TEAE of Bleeding

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

Time frame: From Day of birth to Week 104

Neonate with a TEAE of Infection

Neonate with a TEAE of infection will be reported.

Time frame: From Day of birth to Week 104

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.

Time frame: At Week 52 and Week 104

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.

Time frame: Up to Week 4