Clinical trial • Phase I/II • Dermatology
daratumumab for Toxic epidermal necrolysis
Phase I/II trial of daratumumab for Toxic epidermal necrolysis. 9 participants.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Toxic epidermal necrolysis
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 04-02-2025
- First CTIS Authorization Date
- 29-04-2025
Trial design
Phase I/II trial across 2 sites in France.
- Target Sample Size
- 9
Eligibility
Recruits 9 Vulnerable population selected; no details on consent or assent handling are provided in the available record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling are provided in the available record.
Recruitment
- Planned Sample Size
- 9
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 9
France
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 36
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Centre de référence sur les dermatoses bulleuses toxiques et les toxidermies sévères
- Principal Investigator Name
- Benoit BEN SAID
- Principal Investigator Email
- benoit.ben-said@chu-lyon.fr
- Contact Person Name
- Benoit BEN SAID
- Contact Person Email
- benoit.ben-said@chu-lyon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Allergy and Clilinical Immunology
- Principal Investigator Name
- Florence HACARD
- Principal Investigator Email
- florence.hacard@chu-lyon.fr
- Contact Person Name
- Florence HACARD
- Contact Person Email
- florence.hacard@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Hospices Civils De Lyon
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- DARATUMUMAB
- Active Substance
- daratumumab
- Modality
- Monoclonal antibody
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