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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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: 1. 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 2. 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The participants will be randomized in a 2:1 to receive nipocalimab and placebo treatment.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nipocalimab 		Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
  • Drug: Nipocalimab
    Nipocalimab will be administered as an intravenous infusion.
    Other names:
    • JNJ-80202135
    • M281
    • JNJ-86507083
Placebo Comparator
Placebo 		Participants will receive matching placebo IV qw from randomization through GA Week 35.
  • Drug: Placebo
    Placebo will be administered as an intravenous infusion.

Recruiting Locations

University of California at San Diego
La Jolla, California 92037

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027

UC Davis School of Medicine
Sacramento, California 95817

Childrens Hospital Colorado
Aurora, Colorado 80045

University of Miami
Miami, Florida 33136

Advocate Children's Hospital
Park Ridge, Illinois 60068

Riley Children s Hospital
Indianapolis, Indiana 46202

University of Kentucky Medical Center
Lexington, Kentucky 40536

Johns Hopkins Hospital
Baltimore, Maryland 21287

Midwest Fetal Care Center
Minneapolis, Minnesota 55404

Columbia University Medical Center
New York, New York 10032

University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina 27599-7516

University of Cincinnati
Cincinnati, Ohio 45267

Oregon Health and Science University
Portland, Oregon 97239

Lehigh Valley Hospital
Allentown, Pennsylvania 18103-6218

University of Texas Dell Medical School Department of Women's Health
Austin, Texas 78723

University Of Texas Medical Branch At Galveston
Galveston, Texas 77555

Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia 23507

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.