Clinical trial • Phase I • Dermatology
EGL-003 for Atopic dermatitis
Phase I trial of EGL-003 for Atopic dermatitis. open-label, adaptive. 58 participants.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Atopic dermatitis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-06-2025
- First CTIS Authorization Date
- 01-10-2025
Trial design
open-label, adaptive Phase I trial across 12 sites in Germany, Bulgaria, Poland.
- Open Label
- Yes
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 58
Eligibility
Recruits 58 Vulnerable population not selected; participants are adults (healthy volunteers and adults with autoimmune disease); no special consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; participants are adults (healthy volunteers and adults with autoimmune disease); no special consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 58
- Recruitment Window Months
- 12
- Consent Approach
- Informed consent to be provided by adult participants; no assent or paediatric consent described; specific consent language(s) or materials not specified.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 58
Germany
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 143
- Number Of Sites
- 5
- Number Of Participants
- 40
Sites
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Dermatology
- Contact Person Name
- Stefan Beissert
- Contact Person Email
- Stefan.beissert@ukdd.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Dermatology
- Contact Person Name
- Caroline Mann
- Contact Person Email
- Caroline.Mann@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Dermatology
- Contact Person Name
- Sebastian Volc
- Contact Person Email
- sebastian.volc@med.unituebingen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Dermatology, Venereology and Allergology
- Contact Person Name
- Dora Stoelzl
- Contact Person Email
- dstoelzl@dermatology.uni-kiel.de
- Site Name
- DRK Kliniken Berlin
- Department Name
- Early Phase Clinical Unit (EPCU) Berlin
- Contact Person Name
- Dirk Palla
- Contact Person Email
- dirk.palla@parexel.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 147
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
- Department Name
- Not applicable
- Contact Person Name
- Boyan Kostov
- Contact Person Email
- kostov.derma@abv.bg
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- Dermatology
- Contact Person Name
- Krasimira Vasileva
- Contact Person Email
- vasileva_mclovech@abv.bg
- Site Name
- Medical Center Excelsior OOD
- Department Name
- Not applicable
- Contact Person Name
- Todor Popov
- Contact Person Email
- ted.popov@gmail.com
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- Dermatology
- Contact Person Name
- Kamelia Vekovska
- Contact Person Email
- kvekovska_medconsult@abv.bg
Poland
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 147
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Dermedic Jacek Zdybski
- Department Name
- Dermatology
- Contact Person Name
- Jacek Zdybski
- Contact Person Email
- jacek@zdybski.pl
- Site Name
- Labderm Essence Sp. z o.o.
- Department Name
- Dermatology
- Contact Person Name
- Beata Bergler-Czop
- Contact Person Email
- bbergler-czop@sum.edu.pl
- Site Name
- Dermaceum Sp. z o.o.
- Department Name
- DERMACEUM Centrum Medyczne
- Contact Person Name
- Michal Torz
- Contact Person Email
- m.torz@dermaceum.pl
Sponsor
Primary sponsor
- Full Name
- Egle Therapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- EGL-003
- First In Human
- Yes
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