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

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

Last Updated May 14, 2025

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CR109199

OVERVIEW

Sexes Eligible for Study
female
Age
18+ years
Phase
phase 3

3
Sites
49 Sites
Status

Recruiting

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

ELIGIBILITY

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.

Inclusion Criteria:

1. fetal an

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, Belgium, Brazil, Israel, Japan, Netherlands, United Kingdom, Argentina, Spain, Austria, Canada, France, Germany, Italy, Ireland, Sweden

Country (17)	City or Province (49)	Status
United States	Park Ridge Advocate Children's Hospital	RECRUITING
United States	Chapel Hill University of North Carolina (UNC) - School of Medicine	RECRUITING
United States	Austin University of Texas Dell Medical School Department of Women's Health	RECRUITING
United States	Galveston University Of Texas Medical Branch At Galveston	RECRUITING
Australia	South Brisbane Mater Hospital Brisbane	RECRUITING
Belgium	Bruxelles C.H.U. Brugmann	RECRUITING
Belgium	Leuven Universitair Ziekenhuis Leuven	RECRUITING
Brazil	Belo Horizonte Universidade Federal De Minas Gerais	RECRUITING
Brazil	Goiania Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG	RECRUITING
Brazil	Recife Instituto de Medicina Integral Professor Fernando Figueira	RECRUITING
Brazil	Sao Paulo Hospital Das Clinicas Da Faculdade De Medicina Da USP	RECRUITING
Israel	Petah Tikva Rabin Medical Center	RECRUITING
Israel	Ramat Gan The Chaim Sheba Medical Center	RECRUITING
Japan	Gifu Gifu Prefectural General Medical Center	RECRUITING
Netherlands	Leiden Leiden University Medical Center	RECRUITING
United Kingdom	Birmingham Birmingham Women's Hospital	RECRUITING
United Kingdom	Manchester St.Mary's Hospital	RECRUITING
Argentina	Buenos Aires Hospital Italiano de Buenos Aires	RECRUITING
Australia	Sydney Liverpool Hospital	RECRUITING
Brazil	Rio de Janeiro Instituto D Or de Pesquisa e Ensino IDOR	RECRUITING
Japan	Fukuoka Kyushu University Hospital	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Madrid Hosp. Univ. La Paz	RECRUITING
Spain	Sevilla Hosp. Virgen Del Rocio	RECRUITING
United Kingdom	Oxford John Radcliffe Hospital	RECRUITING
United States	Sacramento UC Davis School of Medicine	RECRUITING
United States	Aurora Childrens Hospital Colorado	RECRUITING
United States	New York Columbia University Medical Center	RECRUITING
United States	Cincinnati University of Cincinnati	RECRUITING
United States	Allentown Lehigh Valley Hospital	RECRUITING
Austria	Vienna Medizinische Universitaet Wien	RECRUITING
Canada	Vancouver BC Women's Hospital University of British Columbia	RECRUITING
Canada	Montreal Centre Hospitalier Sainte Justine	RECRUITING
Canada	Montreal McGill University Health Centre	RECRUITING
France	Lille Cedex CHRU Lille	RECRUITING
France	Paris Hopital Armand Trousseau	RECRUITING
Germany	Giessen Universitaetsklinikum Giessen und Marburg Standort Giessen	RECRUITING
Italy	Rome Fondazione Policlinico Universitario A Gemelli IRCCS	RECRUITING
Japan	Izumi-shi Osaka Women's and Children's Hospital	RECRUITING
Japan	Ota Toho University Medical Center Omori Hospital	RECRUITING
United Kingdom	Leeds Leeds Teaching Hospitals NHS Trust	RECRUITING
United Kingdom	London St George's Hospital	RECRUITING
United States	Baltimore Johns Hopkins Hospital	RECRUITING
United States	Minneapolis Midwest Fetal Care Center	RECRUITING
Argentina	Cordoba Hospital Privado Universitario De Cordoba	RECRUITING
Germany	Berlin Charite Universitaetsmedizin Berlin	RECRUITING
Ireland	Dublin Rotunda Hospital	RECRUITING
Japan	Sendai Miyagi Children's Hospital	COMPLETED
Sweden	Stockholm Karolinska Universitetssjukhuset Huddinge	RECRUITING

Geo Locations

42.01114, -87.84062

35.9132, -79.05584

30.26715, -97.74306

29.30135, -94.7977

-27.48034, 153.02049

50.85045, 4.34878

50.87959, 4.70093

-19.92083, -43.93778

-16.67861, -49.25389

-8.05389, -34.88111

-23.5475, -46.63611

32.08707, 34.88747

32.08227, 34.81065

35.42291, 136.76039

52.15833, 4.49306

52.48142, -1.89983

53.48095, -2.23743

-34.61315, -58.37723

-33.86785, 151.20732

-22.90278, -43.2075

33.6, 130.41667

41.38879, 2.15899

40.4165, -3.70256

37.38283, -5.97317

51.75222, -1.25596

38.58157, -121.4944

39.72943, -104.83192

40.71427, -74.00597

39.12713, -84.51435

40.60843, -75.49018

48.20849, 16.37208

49.24966, -123.11934

45.50884, -73.58781

50.63297, 3.05858

48.85341, 2.3488

50.58727, 8.67554

41.89193, 12.51133

34.48333, 135.43333

36.3, 139.36667

53.79648, -1.54785

51.50853, -0.12574

39.29038, -76.61219

44.97997, -93.26384

-31.4135, -64.18105

52.52437, 13.41053

53.33306, -6.24889

38.26667, 140.86667

59.33258, 18.0649

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

42.01114, -87.84062

35.9132, -79.05584

30.26715, -97.74306

29.30135, -94.7977

-27.48034, 153.02049

50.85045, 4.34878

50.87959, 4.70093

-19.92083, -43.93778

-16.67861, -49.25389

-8.05389, -34.88111

-23.5475, -46.63611

32.08707, 34.88747

32.08227, 34.81065

35.42291, 136.76039

52.15833, 4.49306

52.48142, -1.89983

53.48095, -2.23743

-34.61315, -58.37723

-33.86785, 151.20732

-22.90278, -43.2075

33.6, 130.41667

41.38879, 2.15899

40.4165, -3.70256

37.38283, -5.97317

51.75222, -1.25596

38.58157, -121.4944

39.72943, -104.83192

40.71427, -74.00597

39.12713, -84.51435

40.60843, -75.49018

48.20849, 16.37208

49.24966, -123.11934

45.50884, -73.58781

45.50884, -73.58781

50.63297, 3.05858

48.85341, 2.3488

50.58727, 8.67554

41.89193, 12.51133

34.48333, 135.43333

36.3, 139.36667

53.79648, -1.54785

51.50853, -0.12574

39.29038, -76.61219

44.97997, -93.26384

-31.4135, -64.18105

52.52437, 13.41053

53.33306, -6.24889

38.26667, 140.86667

59.33258, 18.0649

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