Clinical trial • Phase I • Immunology|Neurology
ARGX-119 for Congenital myasthenic syndrome (DOK7-related) | Congenital neuromuscular disorders
Phase I trial of ARGX-119 for Congenital myasthenic syndrome (DOK7-related) | Congenital neuromuscular disorders. 7 participants.
Overview
- Trial Therapeutic Area
- Immunology|Neurology
- Trial Disease
- Congenital myasthenic syndrome (DOK7-related) | Congenital neuromuscular disorders
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 20-05-2024
- First CTIS Authorization Date
- 02-09-2024
Trial design
Phase I trial across 4 sites in Austria, France, Italy and others.
- Target Sample Size
- 7
Recruitment
- Planned Sample Size
- 7
- Recruitment Window Months
- 38
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 10
Austria
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Neurology
- Principal Investigator Name
- Martin Krenn
- Principal Investigator Email
- Martin.krenn@meduniwien.ac.at
- Contact Person Name
- Martin Krenn
- Contact Person Email
- Martin.krenn@meduniwien.ac.at
- Number Of Participants
- 2
France
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 48
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Neuromyologie
- Principal Investigator Name
- Rocio Nur Villar Quiles
- Principal Investigator Email
- rocionur.villarquiles@aphp.fr
- Contact Person Name
- Rocio Nur Villar Quiles
- Contact Person Email
- rocionur.villarquiles@aphp.fr
- Number Of Participants
- 2
Italy
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Unità di Fase I
- Principal Investigator Name
- Lorenzo Maggi
- Principal Investigator Email
- lorenzo.maggi@istituto-besta.it
- Contact Person Name
- Lorenzo Maggi
- Contact Person Email
- lorenzo.maggi@istituto-besta.it
- Number Of Participants
- 2
Spain
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Nuria Muelas Gomez
- Principal Investigator Email
- muelas_nur@gva.es
- Contact Person Name
- Nuria Muelas Gomez
- Contact Person Email
- muelas_nur@gva.es
- Number Of Participants
- 4
Sponsor
Primary sponsor
- Full Name
- Argenx
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- ARGX-119
- Modality
- Monoclonal antibody
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