Resumen

El propósito de este estudio es evaluar la efectividad de nipocalimab en comparación con placebo para reducir el riesgo de anemia fetal (una condición en la que el volumen de glóbulos rojos del bebé cae por debajo de los niveles normales mientras se desarrolla en el útero) con neonatos nacidos vivos en participantes embarazadas con riesgo de enfermedad hemolítica grave del feto y del recién nacido.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 45 YearsSexo: FEMALE

Criterios de inclusión

Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13\^0/7 to Week 18\^6/7 at randomization
History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented:
fetal anemia as result of HDFN or fetal hydrops as result of HDFN or received greater than or equal to (\>=)1 IUT as a result of HDFN or
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 lab test results within values within the study protocol-specified parameters: a) albumin \>= lower limit of normal (LLN); 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
Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical lab tests performed at screening

Criterios de exclusión

Currently pregnant with a multiple gestation (twins or more)
Evidence of fetal anemia prior to randomization in the current pregnancy
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
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 before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention)
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 (IV Ig), 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 lab values during screening
History of an unprovoked pulmonary embolism or history of recurrent deep vein thrombosis (DVT)
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

drug

Placebo

Placebo will be administered as an intravenous infusion.

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Hospital Privado Universitario De Cordoba

Córdoba, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

Estudio de fase 3, aleatorizado, controlado con placebo, doble ciego y multicéntrico para evaluar la eficacia y seguridad de nipocalimab en embarazos con riesgo de enfermedad hemolítica grave del feto y del recién nacido (EHFRN)