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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509434-19-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Nipocalimab | Experimental | 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. |
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| Arm 2: Intravenous Immunoglobins (IVIG) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Count at Birth in a Neonate | Platelet count at birth in a neonate will be reported. | At birth |
| Neonate/Fetus with Outcome of Death | Fetus/neonate with outcome of death will be reported. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41290206 | Derived | Bussel J, Stegmann B, Baker P, Oey A, Jiang Y, Zaha R, Van Valkenburgh H, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(10):1335-1344. doi: 10.1055/a-2753-9323. Epub 2025 Nov 25. |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Intravenous immunoglobulins (IVIG) | Drug | IVIG will be administered intravenously. |
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| Prednisone | Drug | Prednisone will be administered orally. |
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| 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. | 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. | 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. | 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. | At birth |
| Nadir Platelet Count in a Neonate | Nadir platelet count in a neonate will be reported. | Up to 1 Week post birth |
| Neonate Requiring Platelet Transfusion | Neonate who require at least one platelet transfusion will be reported. | Up to 1 Week post birth |
| Number of Platelet Transfusions in Neonate | Number of platelet transfusions per neonate will be reported. | 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. | Up to 1 Week post birth |
| Neonate/Fetus With Adjudicated Bleeding | Neonate/Fetus with adjudicated bleeding will be reported. | 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. | 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. | 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. | 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. | From Day of birth to Week 104 |
| Fetus/Neonate with a TEAE of Bleeding | Fetus/Neonate with a TEAE of bleeding will be reported. | From Day of birth to Week 104 |
| Neonate with a TEAE of Infection | Neonate with a TEAE of infection will be reported. | 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. | 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. | Up to Week 4 |
| UC Davis School of Medicine |
| Recruiting |
| Sacramento |
| California |
| 95817 |
| United States |
| Childrens Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Advocate Children's Hospital | Recruiting | Park Ridge | Illinois | 60068 | United States |
| University of Iowa Hospital and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
| Oregon Health And Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
| Medizinische Universitaet Graz | Recruiting | Graz | 8036 | Austria |
| Medical University Vienna | Recruiting | Vienna | 1090 | Austria |
| Universitaetsklinikum Giessen und Marburg GmbH | Recruiting | Giessen | 35392 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Universitatsklinikum Jena | Recruiting | Jena | 07747 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| Leiden University Medical Center | Recruiting | Leiden | 2333 ZA | Netherlands |
| Instytut Centrum Zdrowia Matki Polki | Recruiting | Lodz | 93 338 | Poland |
| Instytut Matki i Dziecka | Recruiting | Warsaw | 01 211 | Poland |
| Panstwowy Instytut Medyczny MSWiA w Warszawie | Recruiting | Warsaw | 02 507 | Poland |
| Birmingham Women's Hospital | Recruiting | Birmingham | B15 2TG | United Kingdom |
| Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital | Recruiting | Liverpool | L8 7SS | United Kingdom |
| Queen Charlotte's and Chelsea Hospital | Recruiting | London | W12 0HS | United Kingdom |
| John Radcliffe Hospital | Recruiting | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D054098 | Thrombocytopenia, Neonatal Alloimmune |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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