A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hemolytic Disease of the Fetus and Newborn

In brief

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

Key facts

Study ID

NCT05912517

Run by

Janssen Research & Development, LLC

People needed

120

Starts

2023-12-20

Expected to finish

2029-10-08

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• UC Davis School of Medicine — Sacramento, California, United States (enrolling)
• Childrens Hospital Colorado — Aurora, Colorado, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Advocate Children's Hospital — Park Ridge, Illinois, United States (enrolling)
• Riley Children s Hospital — Indianapolis, Indiana, United States (enrolling)
• University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Boston Childrens Hospital — Boston, Massachusetts, United States (enrolling)
• Midwest Fetal Care Center — Minneapolis, Minnesota, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• University of North Carolina (UNC) - School of Medicine — Chapel Hill, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States (enrolling)
• University of Texas Dell Medical School Department of Women's Health — Austin, Texas, United States (enrolling)
• University Of Texas Medical Branch At Galveston — Galveston, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Macon & Joan Brock Virginia Health Sciences at Old Dominion University — Norfolk, Virginia, United States (enrolling)
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina (enrolling)
• Hospital Privado Universitario De Cordoba — Córdoba, Argentina (enrolling)
• Mater Hospital Brisbane — South Brisbane, Australia (enrolling)
• Liverpool Hospital — Sydney, Australia (enrolling)
• Medizinische Universitaet Graz — Graz, Austria (enrolling)
• University of California at San Diego — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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