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

Phase 3RecruitingNCT06449651

Janssen Research & Development, LLC39 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Thrombocytopenia, Neonatal Alloimmune

Interventions

NipocalimabDRUG

Nipocalimab will be administered intravenously.

PlaceboDRUG

Placebo will be administered intravenously.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 (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

Locations (21)

Universitair Ziekenhuis Leuven

Leuven, Belgium

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

Neonate/Fetus With Adjudicated Bleeding

Neonate/fetus With adjudicated bleeding will be reported.

Time frame: Up to 1 Week post birth

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

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

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

Time frame: At birth

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

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

Time frame: At birth

Platelet Count at Birth <50×10^9/L In a Neonate

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

Time frame: At birth

Platelet Count at Birth <150×10^9/L In a Neonate

Platelet count at birth \<150×10\^9/L 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.

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

RECRUITING

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

RECRUITING

CHRU Lille

Lille, France

RECRUITING

Hopital trousseau- APHP

Paris, France

RECRUITING

Semmelweis Egyetem

Budapest, Hungary

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, Italy

RECRUITING

...and 11 more locations

Time frame: At birth

Nadir Platelet Count of a Neonate Over the First Week Post Birth

Nadir platelet count in a neonate will be reported.

Time frame: Upto 1 Week post birth

Neonate/Fetus Requiring Platelet Transfusion(s)

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

Time frame: Up to 1 Week post birth

Number of Platelet Transfusion(s) in Neonate/Fetus

Number of Platelet transfusion(s) per neonate will be reported.

Time frame: Up to 1 Week post birth

Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus

Number of donor exposures for neonates who received platelet transfusion(s) will be reported.

Time frame: Up to 1 Week post birth

Neonate/Fetus With Adjudicated Severe Bleeding

Neonate/Fetus With adjudicated severe bleeding will be reported.

Time frame: Up to 1 week post birth

Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia

Neonates with IVIG for the treatment of thrombocytopenia will be reported.

Time frame: Up to 1 Week post birth

Maternal Participants With Treatment-Emergent Adverse Event (TEAE)

Maternal participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: From randomization up to 24 weeks postpartum

Maternal Participants With Serious Adverse Event (SAE)

Maternal participants with SAE 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. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important.

Time frame: From randomization up to 24 weeks postpartum

Maternal Participants With Adverse Event of Special Interest (AESI)

Maternal participants with an 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. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and/or pulmonary embolism, and clinically significant bleeding.

Time frame: From randomization up to 24 weeks postpartum

Maternal Participants with TEAE Leading to Discontinuation of Study Intervention

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

Time frame: Up to Week 104

Neonate/Infant with TEAE

Neonatal/infant participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to Week 104

Neonate/Infant with SAE

Neonatal/infant participants with SAE 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. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically Important.

Time frame: Up to Week 104

Neonate/Infant with AESI

Neonatal/infant participants with 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. AESIs are considered as: In infants- clinically significant mortalities in fetus/neonates due to maternal infections, and hypogammaglobulinemia.

Time frame: Up to Week 104

Fetus/Neonate With TEAE of Bleeding

Fetus/Neonate with TEAE of Bleeding 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to Week 104

Neonate With TEAE of Infection

Neonate with TEAE of Infection 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to Week 104

Infant Development as Measured by Bayley Scales at Week 52 and Week 104

The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, 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.

Time frame: At Week 52 and 104

Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum

Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.

Time frame: Up to Week 24