Last updated 15 days ago
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
120 patients around the world
Available in Brazil, Argentina
Janssen Research & Development, LLC
6Research sites
120Patients around the world
This study is for people with
Hemolytic Disease
Hemolytic Disease of the Fetus and Newborn
Requirements for the patient
To 45 Years
Female
Medical requirements
- Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13^0/7 to Week 16^6/7 at randomization.History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as:Documented fetal anemia, or received greater than or equal to (>=)1 IUT as a result of HDFN.Fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein (RhE), or RhC antigen above the critical levels (anti-Kell >=4; other >=16) and evidence of an antigen-positive fetus.During the current pregnancy, presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell >= 4; other >=16) based on the designated central lab results at screening.Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cell-free fetal DNA (cffDNA) performed at the central laboratory.Have screening laboratory values within the study protocol-specified parameters: a) albumin, >=2.6 grams (g) per deciliter (g/dL), international system (SI): >=26 gram per liter (g/L); b) alanine transaminase (AST) less than or equal to (<=) 2 × upper limit of normal (ULN); c) alanine transaminase (ALT) <=2 × ULN d) creatinine <=0.8 milligrams per deciliter (mg/dL), SI: <=70.7 micromole per liter (μmol/L), and Serum total immunoglobulins G (IgG) ≥ 600 mg/dL SI: >=6 g/L.Otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening.
- Currently pregnant with a multiple gestation (twins or more).Evidence of fetal anemia prior to randomization in the current pregnancy.Current uncontrolled hypertension.History of myocardial infarction, unstable ischemic heart disease, or stroke.Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant.Has inflammatory or autoimmune diseases requiring immunosuppressive therapies that may jeopardize the safety of the participant.Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months.Is currently receiving systemic corticosteroids or other immunosuppressants for disorders unrelated to the pregnancy.Has received or planning to receive plasmapheresis, immunoadsorption therapy, intravenous immunoglobulin (IVIg), or any immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics during the current pregnancy.Has a severe infection including opportunistic infections.Presence of abnormal (protocol-specified) hematologic laboratory values during screening.History of severe preeclampsia prior to GA Week 34 or severe fetal growth restriction (estimated fetal weight <3rd percentile, based on local fetal growth normative standards) in a previous pregnancy.
Sites
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Universidade Federal de Minas Gerais
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recruiting
Instituto D'or de Pesquisa e Ensino - Rio de Janeiro
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
StudyAZALEA
SponsorJanssen Research & Development, LLC
Conditions
Hemolytic Disease of the Fetus and Newborn
Requirements
To 45 YearsFemale
Unique study IDclinicaltrials.gov
NCT05912517
