Clinical trial • Phase III • Immunology
ABBV-319 for Systemic lupus erythematosus | Sjögren's syndrome
Phase III trial of ABBV-319 for Systemic lupus erythematosus | Sjögren's syndrome. 18 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus | Sjögren's syndrome
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 13-05-2025
- First CTIS Authorization Date
- 28-08-2025
Trial design
Phase III trial across 4 sites in Netherlands, France.
- Target Sample Size
- 18
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 43
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 18
Netherlands
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 124
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Rheumatology & 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
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Rheumatology & Clinical Immunology
- Principal Investigator Name
- Helen Leavis
- Principal Investigator Email
- H.Leavis@umcutrecht.nl
- Contact Person Name
- Helen Leavis
- Contact Person Email
- H.Leavis@umcutrecht.nl
France
- Earliest CTIS Part Ii Submission Date
- 25-06-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 307
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Jacques-Eric GOTTENBERG
- Principal Investigator Email
- jacques-eric.gottenberg@chru-strasbourg.fr
- Contact Person Name
- Jacques-Eric GOTTENBERG
- Contact Person Email
- jacques-eric.gottenberg@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Pôle Cancérologie, Médecine et Immunologie
- 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
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ABBV-319
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
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