Actively Recruiting
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
50
Participants Needed
26
Research Sites
103 weeks
Total Duration
Researchers are evaluating nipocalimab and intravenous immunoglobulin (IVIG) as treatments in pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT), a condition where the mother's immune system attacks the baby's platelets. This Phase 3 study aims to assess the effectiveness and safety of nipocalimab in reducing severe complications such as bleeding or low platelet counts in newborns. The study is sponsored by Janssen Research & Development, LLC. Pregnant women with specific antibodies (anti-HPA-1a and/or anti-HPA-5b) will be randomly assigned to receive either nipocalimab or IVIG along with prednisone. Nipocalimab will be given intravenously from gestational week 13 to 18 until delivery. IVIG is administered intravenously starting at week 12 for high-risk pregnancies or week 20 for standard-risk pregnancies, with oral prednisone added and tapered off after delivery based on tolerance. Participants will be closely monitored through pregnancy and after birth, with evaluations including blood tests for platelet counts, assessments of bleeding events, and developmental testing of the infant up to two years old. Researchers will track safety outcomes for both mother and baby, including adverse events and antibody responses. The study involves follow-up visits up to one year after birth, with the main outcome measured as death, severe bleeding, or very low platelet count in the newborn within one week after birth.
CONDITIONS
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From gestational week 12 or 13-18 until before delivery
Participants receive either Nipocalimab intravenously starting from gestational age week 13 to 18 until before delivery, or Intravenous Immunoglobulins (IVIG) starting from gestational week 12 for high-risk pregnancies or week 20 for standard-risk pregnancies along with oral Prednisone which is tapered off after delivery.
Regular visits during pregnancy as per study protocol
Duration - Up to 104 weeks post birth
Participants and their neonates are monitored for safety and outcomes including adverse events and platelet counts up to 1 week after birth, with additional assessments for the neonate up to 104 weeks.
Visits up to 1 week post birth and ongoing assessments up to 104 weeks
Total: 26 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
UC Davis School of Medicine
Sacramento, California, United States, 95817
Actively Recruiting
3
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
5
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
9
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
10
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
12
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
13
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
14
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
15
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany, 35392
Actively Recruiting
16
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
17
Universitatsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
18
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
19
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
20
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93 338
Actively Recruiting
21
Instytut Matki i Dziecka
Warsaw, Poland, 01 211
Actively Recruiting
22
Panstwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, Poland, 02 507
Actively Recruiting
23
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
24
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS
Actively Recruiting
25
Queen Charlotte's and Chelsea Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
26
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
S
Study Contact
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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James Bussel, Barbara Stegmann, Pamela Baker...
https://pubmed.ncbi.nlm.nih.gov/41290206