Clinical trial • Phase III • Immunology
NIPOCALIMAB for Generalized myasthenia gravis | Myasthenia gravis
Phase III trial of NIPOCALIMAB for Generalized myasthenia gravis | Myasthenia gravis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Generalized myasthenia gravis | Myasthenia gravis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Other antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 22-08-2025
- First CTIS Authorization Date
- 10-12-2025
Trial design
Randomised, open-label, efgartigimod alfa (comparator) versus nipocalimab (investigational). doses and schedules not specified in the provided data.-controlled Phase III trial in Austria, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Efgartigimod alfa (comparator) versus Nipocalimab (investigational). Doses and schedules not specified in the provided data.
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Trial enrols adults (≥18 and <75). Consent expected from adult participants; no assent procedures for minors specified in the provided data..
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected=false). Trial enrols adults (≥18 and <75). Consent expected from adult participants; no assent procedures for minors specified in the provided data.
Inclusion criteria
- {"criterion_text":"- ≥18 years of age and <75 years of age"}
- {"criterion_text":"- AChR antibody positive"}
- {"criterion_text":"- MG-ADL ≥5 with ≥50% as non-ocular"}
- {"criterion_text":"- Has suboptimal response to current stable therapy for generalized Myasthenia Gravis according to the investigator, (specific to arms 1 and 2)"}
- {"criterion_text":"- Total IgG ≥6 g/L, (specific to arms 1 and 2)"}
- {"criterion_text":"- Treatment with efgartigimod intravenously or subcutaneously for ≥1 cycles, (specific to arm 3)"}
- {"criterion_text":"- Participant and HCP agree it is appropriate for the participant to switch to nipocalimab, (specific to arm 3)"}
Exclusion criteria
- {"criterion_text":"- Has received treatment for MG with an FcRn-targeting therapy, (specific to arms 1 and 2)"}
- {"criterion_text":"- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, (specific to arms 1 and 2)"}
- {"criterion_text":"- Current efgartigimod dosing is inconsistent with the label, (specific to arm 3)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2.","definition_or_measurement_approach":"Mean percent change from baseline in total IgG measured and averaged over Weeks 8 to 12; comparison between Arm 1 (nipocalimab) and Arm 2 (efgartigimod)."}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 15
- Consent Approach
- Informed consent is obtained from adult participants (participants are ≥18 and <75). Subject information and ICF documents are provided country-specifically (document titles indicate German, English, Spanish, Italian versions are available). No assent procedures for minors are specified in the provided materials.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 29
Austria
- Earliest CTIS Part Ii Submission Date
- 21-11-2025
- Latest Decision Or Authorization Date
- 14-12-2025
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Neurologie
- Principal Investigator Name
- Fritz Zimprich
- Principal Investigator Email
- friedrich.zimprich@meduniwien.ac.at
- Contact Person Name
- Fritz Zimprich
- Contact Person Email
- friedrich.zimprich@meduniwien.ac.at
- Number Of Participants
- 4
Germany
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 12-12-2025
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 7
Sites
- Site Name
- Klinikum Altenburger Land GmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Jörg Berrouschot
- Principal Investigator Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Contact Person Name
- Jörg Berrouschot
- Contact Person Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Number Of Participants
- unknown
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Christiane Schneider-Gold
- Principal Investigator Email
- christiane.schneider-gold@ruhr-uni-bochum.de
- Contact Person Name
- Christiane Schneider-Gold
- Contact Person Email
- christiane.schneider-gold@ruhr-uni-bochum.de
- Number Of Participants
- unknown
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Neurologie und Neurophysiologie
- Principal Investigator Name
- Christian Keller
- Principal Investigator Email
- christian.keller@uniklinik-freiburg.de
- Contact Person Name
- Christian Keller
- Contact Person Email
- christian.keller@uniklinik-freiburg.de
- Number Of Participants
- unknown
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Veit Rothhammer
- Principal Investigator Email
- veit.rothhammer@uk-erlangen.de
- Contact Person Name
- Veit Rothhammer
- Contact Person Email
- veit.rothhammer@uk-erlangen.de
- Number Of Participants
- unknown
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Gerd Meyer zu Hörste
- Principal Investigator Email
- gerd.mzh@uni-muenster.de
- Contact Person Name
- Gerd Meyer zu Hörste
- Contact Person Email
- gerd.mzh@uni-muenster.de
- Number Of Participants
- unknown
- Site Name
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Felix Kleefeld
- Principal Investigator Email
- felix.kleefeld@bergmannsheil.de
- Contact Person Name
- Felix Kleefeld
- Contact Person Email
- felix.kleefeld@bergmannsheil.de
- Number Of Participants
- unknown
Italy
- Earliest CTIS Part Ii Submission Date
- 29-09-2025
- Latest Decision Or Authorization Date
- 11-12-2025
- Processing Time Days
- 73
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Unità di Neurologia, Dipartimento Neuroscienza, PO Santa Chiara
- Principal Investigator Name
- Michelangelo Maestri Tassoni
- Principal Investigator Email
- m.maestri@ao-pisa.toscana.it
- Contact Person Name
- Michelangelo Maestri Tassoni
- Contact Person Email
- m.maestri@ao-pisa.toscana.it
- Number Of Participants
- unknown
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC di Neurologia
- Principal Investigator Name
- Stefania Morino
- Principal Investigator Email
- stefania.morino2@gmail.com
- Contact Person Name
- Stefania Morino
- Contact Person Email
- stefania.morino2@gmail.com
- Number Of Participants
- unknown
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Neurologia
- Principal Investigator Name
- Raffaele Iorio
- Principal Investigator Email
- raffaele.iorio@policlinicogemelli.it
- Contact Person Name
- Raffaele Iorio
- Contact Person Email
- raffaele.iorio@policlinicogemelli.it
- Number Of Participants
- unknown
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- UOC di Neurofisiopatologia
- Principal Investigator Name
- Francesco Habetswallner
- Principal Investigator Email
- francesco.habetswallner@aocardarelli.it
- Contact Person Name
- Francesco Habetswallner
- Contact Person Email
- francesco.habetswallner@aocardarelli.it
- Number Of Participants
- unknown
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- SSD Immunoterapia e Aferesi Terapeutica , Dip. Neuroscienze Cliniche
- Principal Investigator Name
- Carlo Antozzi
- Principal Investigator Email
- carlo.antozzi@istituto-besta.it
- Contact Person Name
- Carlo Antozzi
- Contact Person Email
- carlo.antozzi@istituto-besta.it
- Number Of Participants
- unknown
Spain
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 34
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Infanta Sofía
- Department Name
- Neurology
- Principal Investigator Name
- Gerardo Gutiérrez-Gutiérrez
- Principal Investigator Email
- G3.neuro@gmail.com
- Contact Person Name
- Gerardo Gutiérrez-Gutiérrez
- Contact Person Email
- G3.neuro@gmail.com
- Number Of Participants
- unknown
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Neurology
- Principal Investigator Name
- Ana Pareja Martínez
- Principal Investigator Email
- iglu@urbasoft.com
- Contact Person Name
- Ana Pareja Martínez
- Contact Person Email
- iglu@urbasoft.com
- Number Of Participants
- unknown
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Principal Investigator Name
- Eugenia Martínez Hernández
- Principal Investigator Email
- emmartinez@clinic.cat
- Contact Person Name
- Eugenia Martínez Hernández
- Contact Person Email
- emmartinez@clinic.cat
- Number Of Participants
- unknown
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Principal Investigator Name
- Eva Martínez Fernández
- Principal Investigator Email
- evam.martinez.sspa@juntadeandalucia.es
- Contact Person Name
- Eva Martínez Fernández
- Contact Person Email
- evam.martinez.sspa@juntadeandalucia.es
- Number Of Participants
- unknown
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- 4g Clinical LLC
- Responsibilities
- sponsorDuties codes: 3
- Name
- Iqvia Inc.
- Responsibilities
- Rater qualification training for edata capture (sponsorDuties code 15)
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Rater qualification training for edata capture (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-80202135
- Active Substance
- NIPOCALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENUS USE
- Route
- Intravenous
- Investigational Product Name
- EFGARTIGIMOD ALFA
- Active Substance
- EFGARTIGIMOD ALFA
- Modality
- Other antibody
- Routes Of Administration
- INTRAVENUS USE
- Route
- Intravenous
- Orphan Designation
- Yes
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