Recruiting
Phase 3

Nipocalimab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05912517

Conditions

Hemolytic Disease of the Fetus and Newborn

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Placebo

Study Details

Brief summary:

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.

Conditions

Hemolytic Disease of the Fetus and Newborn

Study ID

NCT05912517

Start date

Dec 20, 2023

Status verified date

Aug, 2026

Completion date

Oct 8, 2029

Anticipated

Primary completion date

Aug 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nipocalimab

Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.

placebo comparator: Placebo

Participants will receive matching placebo IV qw from randomization through GA Week 35.

Interventions

Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

Placebo

Placebo will be administered as an intravenous infusion.

Primary outcome measure

  • Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death [ Time Frame: From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

University of California at San Diego

Recruiting

La Jolla, California, United States, 92037

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

UC Davis School of Medicine

Recruiting

Sacramento, California, United States, 95817

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

University of Miami

Recruiting

Miami, Florida, United States, 33136

Advocate Children's Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Midwest Fetal Care Center

Recruiting

Minneapolis, Minnesota, United States, 55404

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

University of North Carolina (UNC) - School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599-7516

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103-6218

University of Texas Dell Medical School Department of Women's Health

Recruiting

Austin, Texas, United States, 78723

University Of Texas Medical Branch At Galveston

Recruiting

Galveston, Texas, United States, 77555

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23507

BC Women's Hospital University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Centre Hospitalier Sainte Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.