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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135FNAIT3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-504307-88-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipocalimab | Active Comparator | Maternal participants will receive nipocalimab Intravenously (IV). |
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| Placebo | Placebo Comparator | Maternal participants will receive placebo IV. |
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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 |
|---|---|---|
| Neonate/Fetus With Adjudicated Bleeding | Neonate/fetus With adjudicated bleeding will be reported. | Up to 1 Week post birth |
| Platelet Count at Birth in a Neonate | Platelet count at birth in a neonate will be reported. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 3000 | Belgium | ||
| Instituto de Medicina Integral Professor Fernando Figueira |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40720970 | Derived | Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28. |
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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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| Placebo | Drug | Placebo will be administered intravenously. |
|
| At birth |
| Neonate/Fetus with Outcome of Death | Fetus/neonate with outcome of death will be reported. | 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. | 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. | 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. | 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. | At birth |
| Nadir Platelet Count of a Neonate Over the First Week Post Birth | Nadir platelet count in a neonate will be reported. | Upto 1 Week post birth |
| Neonate/Fetus Requiring Platelet Transfusion(s) | Neonate(s) who require at least one platelet transfusion(s) will be reported. | Up to 1 Week post birth |
| Number of Platelet Transfusion(s) in Neonate/Fetus | Number of Platelet transfusion(s) per neonate will be reported. | 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. | Up to 1 Week post birth |
| Neonate/Fetus With Adjudicated Severe Bleeding | Neonate/Fetus With adjudicated severe bleeding will be reported. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to Week 24 |
| Recruiting |
| Recife |
| 50070-902 |
| Brazil |
| Instituto D Or de Pesquisa e Ensino IDOR | Recruiting | Rio de Janeiro | 22281 00 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | Recruiting | São Paulo | 05403 000 | Brazil |
| CHRU Lille | Recruiting | Lille | 59000 | France |
| Hopital trousseau- APHP | Recruiting | Paris | 75012 | France |
| Semmelweis Egyetem | Recruiting | Budapest | 1082 | Hungary |
| Sheba Medical Center | Recruiting | Ramat Gan | 5262000 | Israel |
| Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
| Haukeland University Hospital | Recruiting | Bergen | 5009 | Norway |
| Oslo University Hospital HF Ulleval sykehus | Recruiting | Oslo | 0455 | Norway |
| Universitetssykehuset Nord-Norge HF | Recruiting | Tromsø | 9019 | Norway |
| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
| Univerzitna nemocnica L. Pasteura Kosice | Recruiting | Košice | 04190 | Slovakia |
| Univerzitná nemocnica Martin | Recruiting | Martin | 036 01 | Slovakia |
| Fakultna nemocnica s poliklinikou Nove Zamky | Recruiting | Nové Zámky | 940 34 | Slovakia |
| Univerzitetni klinicni center Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
| Hosp. Virgen Del Rocio | Completed | Seville | 41013 | Spain |
| Karolinska Universitetssjukhuset Huddinge | Recruiting | Stockholm | SE-141 86 | Sweden |
| Centre Hospitalier Universitaire Vaudois CHUV | Recruiting | Lausanne | 1011 | Switzerland |
| 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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