Clinical trial NCT06533098: A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Official title: Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thrombocytopenia, Neonatal Alloimmune
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
timeFrame: Up to 1 Week post birth
Secondary outcomes:
measure: Platelet Count at Birth in a Neonate
timeFrame: At birth
measure: Neonate/Fetus with Outcome of Death
timeFrame: Up to 1 Week post birth
measure: Neonate with Platelet Count at Birth <10*10^9/L
timeFrame: At birth
measure: Neonate with Platelet Count at Birth <30*10^9/L
timeFrame: At birth
measure: Neonate with Platelet Count at Birth <50*10^9/L
timeFrame: At birth
measure: Neonate with Platelet Count at Birth <150*10^9/L
timeFrame: At birth
measure: Nadir Platelet Count in a Neonate
timeFrame: Up to 1 Week post birth
measure: Neonate Requiring Platelet Transfusion
timeFrame: Up to 1 Week post birth
measure: Number of Platelet Transfusions in Neonate
timeFrame: Up to 1 Week post birth
measure: Number of Donor Exposures for Platelet Transfusions in Neonate
timeFrame: Up to 1 Week post birth
measure: Neonate/Fetus With Adjudicated Bleeding
timeFrame: Up to 1 Week post birth
measure: Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia
timeFrame: Up to 1 Week post birth
measure: Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)
timeFrame: Up to Week 24
measure: Maternal Participant with TEAE Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 24
measure: Neonate/Infant With TEAE, SAE and AESI
timeFrame: From Day of birth to Week 104
measure: Fetus/Neonate with a TEAE of Bleeding
timeFrame: From Day of birth to Week 104
measure: Neonate with a TEAE of Infection
timeFrame: From Day of birth to Week 104
measure: Bayley Scales Assessment for Infant Development
timeFrame: At Week 52 and Week 104
measure: Maternal Participants with Incidence of Antibodies to Nipocalimab
timeFrame: Up to Week 4
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Vienna
country: Austria
facility: Medical University Vienna
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Warszawa
country: Poland
facility: Instytut Matki i Dziecka
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA w Warszawie
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
city: London
country: United Kingdom
facility: Queen Charlotte's and Chelsea Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: