Clinical trial • Phase III • Immunology|Rare Disease
NIPOCALIMAB for Hemolytic disease of the fetus and newborn (HDFN)
Phase III trial of NIPOCALIMAB for Hemolytic disease of the fetus and newborn (HDFN).
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Hemolytic disease of the fetus and newborn (HDFN)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 11-09-2023
- First CTIS Authorization Date
- 18-01-2024
Trial design
Randomised, saline, 0.9% sodium chloride solution for injection (placebo) administered as placebo comparator; product listed as 'saline, 0.9% sodium chloride solution for injection' (no dose/schedule specified in ctis record).-controlled Phase III trial in Austria, Spain, Sweden and others.
- Randomised
- Yes
- Comparator
- Saline, 0.9% Sodium Chloride Solution for Injection (placebo) administered as placebo comparator; product listed as 'Saline, 0.9% Sodium Chloride Solution for Injection' (no dose/schedule specified in CTIS record).
- Target Sample Size
- 92
Eligibility
Recruits 92 Vulnerable population flag is selected. The trial includes pregnant participants; informed consent materials and procedures are provided specifically for maternal participants (SIS and ICF Main Maternal / Maternal Participant). Subject information and informed consent forms for Parent/Guardian are available (REDACTED_L1_SIS and ICF Parent Guardian / Parent Legal Guardian) and eConsent materials are provided. Multiple language translations and parent/guardian consent documents are included in the submission packages, indicating provision for vulnerable-subject consent processes and parent/legal-guardian documentation where applicable..
- Pregnancy Exclusion
- Currently pregnant with a multiple gestation (twins or more).
- Vulnerable Population
- Vulnerable population flag is selected. The trial includes pregnant participants; informed consent materials and procedures are provided specifically for maternal participants (SIS and ICF Main Maternal / Maternal Participant). Subject information and informed consent forms for Parent/Guardian are available (REDACTED_L1_SIS and ICF Parent Guardian / Parent Legal Guardian) and eConsent materials are provided. Multiple language translations and parent/guardian consent documents are included in the submission packages, indicating provision for vulnerable-subject consent processes and parent/legal-guardian documentation where applicable.
Inclusion criteria
- {"criterion_text":"-Female, 18 (or the legal age of consent if above 18 in local regions) to 45 years of age, inclusive, at the time of informed consent."}
- {"criterion_text":"-Pregnant and an estimated GA (based on ultrasound dating) from Week 13^0/7 and Week 18^6/7 at randomization."}
- {"criterion_text":"-History of severe HDFN in a prior pregnancy, defined as documented: a. fetal anemia* s result of HDFN* or fetal hydrops** as a result of HDFN, or received ≥1 IUT as a result of HDFN. *defined as fetal hemoglobin level <0.84 MoM (Section 8.2.1.2). Fetal hemoglobin (g/dL) can be calculated using hematocrit (%)/3. **defined as the presence of ≥2 abnormal fluid collections in the fetus as ascites, plural effusions, pericardial effusion, and generalized skin edema (skin thickness >5 mm. OR b. Fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for RhD, Kell, Rhc, RhE, or RhC antigen above the critical levels (anti-Kell ≥4; other ≥16) and evidence of an antigen-positive fetus (When these tests have not been performed as part of regional/local clinical practice, alternative confirmation of HDFN, after consultation with the sponsor, may be considered)."}
- {"criterion_text":"-During the current pregnancy, presence of maternal alloantibody to RhD, Kell, 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."}
- {"criterion_text":"-Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cffDNA performed at the central laboratory."}
Exclusion criteria
- {"criterion_text":"-Currently pregnant with a multiple gestation (twins or more)."}
- {"criterion_text":"-2.1 Criterion amended per Amendment 6.Evidence of fetal anemia by ultrasound or repeated MCA-PSV ≥1.5 MoM* prior to randomization in the current pregnancy. *In the absence of other evidence of fetal anemia on ultrasound, inability to measure MCA-PSV before GA 14 weeks 0 days, secondary to concerns of safety/accuracy, will not be considered an exclusion."}
- {"criterion_text":"-3.2 Criterion amended per Amendment 6. History of severe preeclampsia prior to GA Week 34 or severe FGR (EFW<3rd percentile, based on local fetal growth normative standards) in a previous pregnancy. Note: for countries where the percentiles are not used in clinical practice, local country measures (standard deviations) equivalent to <3rd percentile may be considered after consultation with the sponsor."}
- {"criterion_text":"-Current uncontrolled hypertension."}
- {"criterion_text":"-History of myocardial infarction, unstable ischemic heart disease, or stroke."}
Endpoints
Primary endpoints
- {"endpoint_text":"-The proportion of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period (through 4 weeks of age or 41 weeks PMA, whichever is later).","definition_or_measurement_approach":"Neonatal period defined as through 4 weeks of age or 41 weeks postmenstrual age (PMA), whichever is later; endpoint is the proportion of pregnancies without fetal loss, intrauterine transfusion (IUT), hydrops fetalis, or neonatal death during that neonatal period."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 92
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent is provided by the maternal participant (Maternal Participant ICF / SIS and ICF Main Maternal). eConsent is available (eConsent materials and screenshots referenced). Parent/legal guardian ICFs and SIS for Parent/Guardian are provided where applicable. Consent and participant materials are provided in multiple languages (documentation includes English, Spanish, French, Dutch, German, Arabic, Romanian, Tigrinya, Polish, Italian, Swedish and others as per country-specific submission packages).
Methods
- Use of patient-facing recruitment materials including Participant Recruitment Brochures and Clinical Trial Patient Education Booklets (K2_Clinical Trial Patient Education Booklet) distributed at sites.
- Digital/web advertising: Participant Recruitment Web Ads for multiple countries (web ads referenced in K2 materials).
- Print advertising and posters: Participant Recruitment Print Ads and Professional Recruitment Posters (K2_Participant Recruitment Print Ad; K2_Professional Recruitment Poster).
- Social media advertisements and site social toolkits (documents labelled Social Media Advertisement / Social_ToolKit).
- Patient database letters and telephone screens to contact potential participants (Patient Database Letter, Telephone Screen materials).
- Colleague referral and professional outreach (Colleague Referral Letter, Professional Recruitment Brochure).
- Site-based recruitment via hospital/clinic referral and local study staff.
- Use of eConsent and electronic participant-facing materials (eConsent submission materials and eConsent screenshots) to facilitate remote consent.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 31
Austria
- Earliest CTIS Part Ii Submission Date
- 05-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Medical University of Graz, Division of Obstetrics, Neue Stiftingtalstraße 6
- Department Name
- Department of Obstetrics and Gynecology
- Principal Investigator Name
- Philip Klaritsch
- Principal Investigator Email
- philipp.klaritsch@medunigraz.at
- Contact Person Name
- Philip Klaritsch
- Contact Person Email
- philipp.klaritsch@medunigraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine
- Principal Investigator Name
- Alex Farr
- Principal Investigator Email
- alex.farr@meduniwien.ac.at
- Contact Person Name
- Alex Farr
- Contact Person Email
- alex.farr@meduniwien.ac.at
Spain
- Earliest CTIS Part Ii Submission Date
- 31-10-2023
- Latest Decision Or Authorization Date
- 22-01-2024
- Processing Time Days
- 83
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- gynecology
- Principal Investigator Name
- Jose Luis Bartha Rasero
- Principal Investigator Email
- josel.bartha@salud.madrid.org
- Contact Person Name
- Jose Luis Bartha Rasero
- Contact Person Email
- josel.bartha@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- gynecology
- Principal Investigator Name
- Lucas Ángel Cerrillos Gonzalez
- Principal Investigator Email
- lucas.cerrillos.sspa@juntadeandalucia.es
- Contact Person Name
- Lucas Ángel Cerrillos Gonzalez
- Contact Person Email
- lucas.cerrillos.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- gynecology
- Principal Investigator Name
- Maria Ángeles Sánchez Durán
- Principal Investigator Email
- angeles.sanchezduran@vallhebron.cat
- Contact Person Name
- Maria Ángeles Sánchez Durán
- Contact Person Email
- angeles.sanchezduran@vallhebron.cat
Sweden
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 19-01-2024
- Processing Time Days
- 45
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Center for Fetal Medicine
- Principal Investigator Name
- Gunilla Ajne
- Principal Investigator Email
- gunilla.ajne@regionstockholm.se
- Contact Person Name
- Gunilla Ajne
- Contact Person Email
- gunilla.ajne@regionstockholm.se
Italy
- Earliest CTIS Part Ii Submission Date
- 24-10-2023
- Latest Decision Or Authorization Date
- 18-01-2024
- Processing Time Days
- 86
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento di Scienze della Salute della Donna, del Bambino e di Sanità Pubblica
- Principal Investigator Name
- Marco De Santis
- Principal Investigator Email
- marco.desantis@unicatt.it
- Contact Person Name
- Marco De Santis
- Contact Person Email
- marco.desantis@unicatt.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Ostetricia
- Principal Investigator Name
- Irene Cetin
- Principal Investigator Email
- irene.cetin@policlinico.mi.it
- Contact Person Name
- Irene Cetin
- Contact Person Email
- irene.cetin@policlinico.mi.it
Germany
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 18-01-2024
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Obstetrics and Fetal Medicine
- Principal Investigator Name
- Stefan Verlohren
- Principal Investigator Email
- s.verlohren@uke.de
- Contact Person Name
- Stefan Verlohren
- Contact Person Email
- s.verlohren@uke.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Obstetrics
- Principal Investigator Name
- Iris Dressler-Steinbach
- Principal Investigator Email
- iris.dressler-steinbach@charite.de
- Contact Person Name
- Iris Dressler-Steinbach
- Contact Person Email
- iris.dressler-steinbach@charite.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Universitätsklinikum Gießen und Marburg GmbH, Sektion Hämostaseologie
- Principal Investigator Name
- Ulrich Sachs
- Principal Investigator Email
- Ulrich.sachs@med.uni-giessen.de
- Contact Person Name
- Ulrich Sachs
- Contact Person Email
- Ulrich.sachs@med.uni-giessen.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-12-2023
- Latest Decision Or Authorization Date
- 18-01-2024
- Processing Time Days
- 45
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Department Name
- Department of Gynecology and Obstetrics
- Principal Investigator Name
- Jacques Jani
- Principal Investigator Email
- jacques.jani@chu-brugmann.be
- Contact Person Name
- Jacques Jani
- Contact Person Email
- jacques.jani@chu-brugmann.be
- Site Name
- UZ Leuven
- Department Name
- Department of Obstetrics and Gynaecology
- Principal Investigator Name
- Roland Devlieger
- Principal Investigator Email
- roland.devlieger@uzleuven.be
- Contact Person Name
- Roland Devlieger
- Contact Person Email
- roland.devlieger@uzleuven.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-12-2023
- Latest Decision Or Authorization Date
- 22-01-2024
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Academisch Ziekenhuis Leiden
- Department Name
- Department of Obstetrics and Gynaecology
- Principal Investigator Name
- Joanne (E.J.T.) Verweij
- Principal Investigator Email
- e.j.t.verweij@lumc.nl
- Contact Person Name
- Joanne (E.J.T.) Verweij
- Contact Person Email
- e.j.t.verweij@lumc.nl
Ireland
- Earliest CTIS Part Ii Submission Date
- 05-04-2024
- Latest Decision Or Authorization Date
- 03-05-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Rotunda Hospital
- Department Name
- Rotunda Private Clinics
- Principal Investigator Name
- Fergal Malone
- Principal Investigator Email
- fmalone@rcsi.ie
- Contact Person Name
- Fergal Malone
- Contact Person Email
- fmalone@rcsi.ie
France
- Earliest CTIS Part Ii Submission Date
- 28-09-2023
- Latest Decision Or Authorization Date
- 19-01-2024
- Processing Time Days
- 113
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Fetal Medecine Department
- Principal Investigator Name
- Jean-Marie Jouannic
- Principal Investigator Email
- Jean-marie.jouannic@aphp.fr
- Contact Person Name
- Jean-Marie Jouannic
- Contact Person Email
- Jean-marie.jouannic@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Department of obstetrics and fetal medicine
- Principal Investigator Name
- Anthony ATALLAH
- Principal Investigator Email
- anthony.atallah@chu-lyon.fr
- Contact Person Name
- Anthony ATALLAH
- Contact Person Email
- anthony.atallah@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Gynecology-Obstetrics Department
- Principal Investigator Name
- Veronique Houfflin-Debarge
- Principal Investigator Email
- Veronique.DEBARGE@chu-lille.fr
- Contact Person Name
- Veronique Houfflin-Debarge
- Contact Person Email
- Veronique.DEBARGE@chu-lille.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Perinatologii Poloznictwa i Ginekologii
- Principal Investigator Name
- Grzesiak Mariusz
- Principal Investigator Email
- mariusz.grzesiak@iczmp.edu.pl
- Contact Person Name
- Grzesiak Mariusz
- Contact Person Email
- mariusz.grzesiak@iczmp.edu.pl
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Poloznictwa i Perinatologii
- Principal Investigator Name
- Mirosław Wielgos
- Principal Investigator Email
- miroslaw.wielgos@cskmswia.gov.pl
- Contact Person Name
- Mirosław Wielgos
- Contact Person Email
- miroslaw.wielgos@cskmswia.gov.pl
- Site Name
- Instytut Matki I Dziecka
- Department Name
- Klinika Poloznictwa i Ginekologii
- Principal Investigator Name
- Tadeusz Issat
- Principal Investigator Email
- tadeusz.issat@imid.med.pl
- Contact Person Name
- Tadeusz Issat
- Contact Person Email
- tadeusz.issat@imid.med.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 53
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Klinika gynekologie, porodnictvi a neonatologie 1. LF a VFN
- Principal Investigator Name
- Pavel Calda
- Principal Investigator Email
- pavel.calda@vfn.cz
- Contact Person Name
- Pavel Calda
- Contact Person Email
- pavel.calda@vfn.cz
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- eConsent
- Name
- Iqvia Rds Inc.
- Responsibilities
- NCC Management
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Operational/site services (sponsor duty code 4)
- Name
- 4g Clinical LLC
- Responsibilities
- Site services / study support (sponsor duty code 3)
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"eConsent","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient transportation and subject compensation service","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"PROs/ClinROs","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"IPE Materials","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"HHS","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Sanquin Diagnostiek B.V.","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Reviewer","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"NCC Management","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data capture / eCOA (sponsor duty code 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"Laboratory/services (sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Study supplies","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Grifols Laboratory Solutions Inc.","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Site management / other (sponsor duty code 3)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Billiontoone Inc.","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-80202135 (SOLUTION FOR INFUSION)
- Active Substance
- NIPOCALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Orphan Designation
- Yes
- Investigational Product Name
- JNJ-80202135 (SOLUTION FOR INJECTION)
- Active Substance
- NIPOCALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Investigational Product Name
- Saline, 0.9% Sodium Chloride Solution for Injection (placebo)
- Modality
- Other
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