Clinical trial • Phase I • Immunology
AZD5492 for Systemic lupus erythematosus | Rheumatoid arthritis | Idiopathic inflammatory myopathy
Phase I trial of AZD5492 for Systemic lupus erythematosus | Rheumatoid arthritis | Idiopathic inflammatory myopathy. 30 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus | Rheumatoid arthritis | Idiopathic inflammatory myopathy
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 21-02-2025
- First CTIS Authorization Date
- 18-06-2025
Trial design
Phase I trial across 15 sites in France, Germany, Spain and others.
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected; no details on consent or assent handling available in source..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling available in source.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 33
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 32
France
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 278
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Rheumatology
- Principal Investigator Name
- Christian Jorgensen
- Principal Investigator Email
- c-jorgensen@chu-montpellier.fr
- Contact Person Name
- Christian Jorgensen
- Contact Person Email
- c-jorgensen@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Nephrlogy and Immunology
- Principal Investigator Name
- Stanislas Faguer
- Principal Investigator Email
- faguer.s@chu-toulouse.fr
- Contact Person Name
- Stanislas Faguer
- Contact Person Email
- faguer.s@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Rheumatology
- Principal Investigator Name
- Christophe Richez
- Principal Investigator Email
- christophe.richez@chu-bordeaux.fr
- Contact Person Name
- Christophe Richez
- Contact Person Email
- christophe.richez@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Rheumatology
- Principal Investigator Name
- Zahir Amoura
- Principal Investigator Email
- Zahir.amoura@aphp.fr
- Contact Person Name
- Zahir Amoura
- Contact Person Email
- Zahir.amoura@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Rheumatology
- Principal Investigator Name
- Marc Scherlinger
- Principal Investigator Email
- marc.scherlinger@chru-strasbourg.fr
- Contact Person Name
- Marc Scherlinger
- Contact Person Email
- marc.scherlinger@chru-strasbourg.fr
- Site Name
- CHRU De Nancy
- Department Name
- Internal medicine
- Principal Investigator Name
- Thomas Moulinet
- Principal Investigator Email
- t.moulinet@chru-nancy.fr
- Contact Person Name
- Thomas Moulinet
- Contact Person Email
- t.moulinet@chru-nancy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Internal medicine
- Principal Investigator Name
- Olivier Benveniste
- Principal Investigator Email
- olivier.benveniste@psl.aphp.fr
- Contact Person Name
- Olivier Benveniste
- Contact Person Email
- olivier.benveniste@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Rheumatology
Germany
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 277
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Rheumatologie & Immunologie
- Principal Investigator Name
- Ricardo Grieshaber-Bouyer
- Principal Investigator Email
- ricardo.grieshaber@fau.de
- Contact Person Name
- Ricardo Grieshaber-Bouyer
- Contact Person Email
- ricardo.grieshaber@fau.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Department I of Internal Medicine
- Principal Investigator Name
- Philipp Koehler
- Principal Investigator Email
- philipp.koehler@uk-koeln.de
- Contact Person Name
- Philipp Koehler
- Contact Person Email
- philipp.koehler@uk-koeln.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Hematology/Oncology
- Principal Investigator Name
- Dimitrios Mougiakakos
- Principal Investigator Email
- dimitrios.mougiakakos@med.ovgu.de
- Contact Person Name
- Dimitrios Mougiakakos
- Contact Person Email
- dimitrios.mougiakakos@med.ovgu.de
Spain
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 299
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Rheumatology
- Principal Investigator Name
- Raul Veroz
- Principal Investigator Email
- raulveroz@hotmail.com
- Contact Person Name
- Raul Veroz
- Contact Person Email
- raulveroz@hotmail.com
- Site Name
- Hospital De Merida
- Department Name
- Rheumatology
- Principal Investigator Name
- Maria Julia Barbado
- Principal Investigator Email
- gerente.merida@salud-juntaex.es
- Contact Person Name
- Maria Julia Barbado
- Contact Person Email
- gerente.merida@salud-juntaex.es
- Site Name
- Hospital Universitario Rio Hortega
- Department Name
- Internal Medicine
- Principal Investigator Name
- Juan Miguel Sanchez
- Principal Investigator Email
- rconvi@saludcastillayleon.es
- Contact Person Name
- Juan Miguel Sanchez
- Contact Person Email
- rconvi@saludcastillayleon.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 05-06-2025
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 287
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Academisch Medisch Centrum
- Department Name
- Rheumatology and Clinical Immunology
- Principal Investigator Name
- Sander Tas
- Principal Investigator Email
- s.w.tas@amsterdamumc.nl
- Contact Person Name
- Sander Tas
- Contact Person Email
- s.w.tas@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD5492
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