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New drug could prevent Life-Threatening fetal anemia in High-Risk pregnancies

NCT ID NCT05912517

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether the drug nipocalimab can reduce the risk of severe anemia in unborn babies whose mothers have a condition called hemolytic disease of the fetus and newborn (HDFN). The study enrolls 120 pregnant women with a history of severe HDFN. Participants receive either nipocalimab or a placebo by IV infusion. The goal is to see if the drug helps avoid fetal loss, the need for fetal blood transfusions, or other serious complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nipocalimab
What this could lead to
If it works, nipocalimab could offer a new way to prevent severe anemia and complications in babies at risk for HDFN, reducing the need for risky fetal blood transfusions.
What could go wrong
This is a phase 3 trial, but it is still experimental. The drug may not work better than placebo, and there could be side effects for the mother or baby. Results may not apply to all pregnancies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fetal erythroblastosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemolytic disease of the fetus and newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    62 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Children's Hospital

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • BC Women's Hospital University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • Birmingham Women's Hospital

    RECRUITING

    Birmingham, B15 2TG, United Kingdom

  • Boston Childrens Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • C.H.U. Brugmann

    RECRUITING

    Brussels, 1020, Belgium

  • CHRU Lille

    RECRUITING

    Lille, 59000, France

  • Centre Hospitalier Sainte Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Charite Universitaetsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Childrens Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Faculdade de Medicina Universidade Federal de Minas Gerais

    RECRUITING

    Belo Horizonte, 30130 100, Brazil

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Gifu Prefectural General Medical Center

    RECRUITING

    Gifu, 500-8717, Japan

  • Hadassah mount scopus

    RECRUITING

    Jerusalem, 91240, Israel

  • Hopital Armand Trousseau

    RECRUITING

    Paris, 75012, France

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hosp. Univ. La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hosp. Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

    RECRUITING

    Bron, 69500, France

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    RECRUITING

    São Paulo, 05403-010, Brazil

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1199, Argentina

  • Hospital Privado Universitario De Cordoba

    RECRUITING

    Córdoba, X5016KEH, Argentina

  • Hospital das Clinicas - UFG

    RECRUITING

    Goiânia, 74605 020, Brazil

  • IDOR - Regional Rio de Janeiro

    RECRUITING

    Rio de Janeiro, 22281 100, Brazil

  • Instituto de Medicina Integral Professor Fernando Figueira

    RECRUITING

    Recife, 50070902, Brazil

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90027, United States

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Stockholm, 14186, Sweden

  • Kings College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kyushu University Hospital

    COMPLETED

    Fukuoka, 812 8582, Japan

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103-6218, United States

  • Leiden University Medical Center

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Liverpool Hospital

    RECRUITING

    Sydney, 2170, Australia

  • Macon & Joan Brock Virginia Health Sciences at Old Dominion University

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Mater Hospital Brisbane

    RECRUITING

    South Brisbane, 4101, Australia

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Medizinische Universitaet Graz

    RECRUITING

    Graz, 8036, Austria

  • Medizinische Universitaet Wien

    RECRUITING

    Vienna, 1090, Austria

  • Midwest Fetal Care Center

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Miyagi Childrens Hospital

    COMPLETED

    Sendai, 989-3126, Japan

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Osaka Womens and Childrens Hospital

    RECRUITING

    Izumi-shi, 594-1101, Japan

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 49100, Israel

  • Riley Children s Hospital

    SUSPENDED

    Indianapolis, Indiana, 46202, United States

  • Rotunda Hospital

    RECRUITING

    Dublin, D01 P5W9, Ireland

  • St Georges Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St.Mary's Hospital

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Toho University Medical Center Omori Hospital

    RECRUITING

    Ōta-ku, 143-8541, Japan

  • UC Davis School of Medicine

    RECRUITING

    Sacramento, California, 95817, United States

  • Universitaetsklinikum Giessen und Marburg Standort Giessen

    RECRUITING

    Giessen, 35392, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Of Texas Medical Branch At Galveston

    RECRUITING

    Galveston, Texas, 77555, United States

  • University of California at San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Kentucky Medical Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of North Carolina (UNC) - School of Medicine

    RECRUITING

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

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

    RECRUITING

    Austin, Texas, 78723, United States

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Other studies related to the condition(s) this trial covers.