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

NCT ID NCT05912517

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

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
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
Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG
RECRUITING

Goiânia, 74605-050, 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
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING

Rio de Janeiro, 22281 100, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
RECRUITING

Recife, 50070902, Brazil
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
RECRUITING

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
RECRUITING

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
Universidade Federal De Minas Gerais
RECRUITING

Belo Horizonte, 30130100, Brazil
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