Evaluating nipocalimab for preventing fetal and neonatal alloimmune thrombocytopenia
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
This study is testing whether nipocalimab can help pregnant women with a history of a blood condition called fetal and neonatal alloimmune thrombocytopenia prevent serious problems for their babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | nipocalimab |
| Locations | 21 sites (Leuven and 20 other locations) |
| Trial ID | NCT06449651 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of nipocalimab in comparison to a placebo for reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pregnant women with a history of FNAIT and specific genetic markers will be enrolled between 13 to 18 weeks of gestation. Participants will receive either nipocalimab or a placebo, and their outcomes will be monitored to determine the drug's efficacy in preventing complications associated with FNAIT.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with a history of FNAIT and specific genetic markers indicating risk.
Not a fit: Patients who do not have a history of FNAIT or lack the necessary genetic markers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of severe complications in newborns affected by FNAIT.
How similar studies have performed: Other studies have explored treatments for FNAIT, but the specific use of nipocalimab represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leuven and 20 other locations
- Universitair Ziekenhuis Leuven — Leuven, Belgium (Recruiting)
- 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)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Oslo University Hospital HF Ulleval sykehus — Oslo, Norway (Recruiting)
- Universitetssykehuset Nord-Norge HF — Tromsø, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Univerzitna nemocnica L. Pasteura Kosice — Košice, Slovakia (Recruiting)
- Univerzitná nemocnica Martin — Martin, Slovakia (Recruiting)
- Fakultna nemocnica s poliklinikou Nove Zamky — Nové Zámky, Slovakia (Recruiting)
- Univerzitetni klinicni center Ljubljana — Ljubljana, Slovenia (Recruiting)
- Hosp. Virgen Del Rocio — Seville, Spain (Recruiting)
- Karolinska Universitetssjukhuset Huddinge — Stockholm, Sweden (Recruiting)
- Centre Hospitalier Universitaire Vaudois CHUV — Lausanne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.