Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
306
Countries
1
Sites
13
Chronic stable plaque psoriasis
Key facts
- Sponsor
- Dermapharm AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 20 Sep 2022 → 25 Aug 2025
- Decision date (initial)
- 2024-08-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514788-24-00
- EudraCT number
- 2020-004081-19
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic stable plaque psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10050576 | Psoriasis vulgaris | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dermapharm AG
- Sponsor organisation
- Dermapharm AG
- Address
- Lil-Dagover-Ring 7, Geiselgasteig Geiselgasteig
- City
- Gruenwald
- Postcode
- 82031
- Country
- Germany
Scientific contact point
- Organisation
- Dermapharm AG
- Contact name
- Department of Clinical Research
Public contact point
- Organisation
- Dermapharm AG
- Contact name
- Department of Clinical Research
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 306 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Hautarztzentrum Hamm
Hautarztzentrum Hamm, Friedrichstraße 20, 59065, Hamm
Praxis Dr. med. Abdou Zarzour
Praxis Dr. med. Abdou Zarzour, Große Steinstr. 12, 06108, Halle
Haut-und Lasercentrum Potsdam - Dr. med. Tanja Fischer
Haut-und Lasercentrum Potsdam, Kurfürstenstr. 40, 14467, Potsdam
Gemeinschaftspraxis Weber & Crainic
Gemeinschaftspraxis R. Weber & A. Crainic, Böheimstrasse 8, 86153, Augsburg
Praxis Fuer Dermatologie Und Venerologie
Praxis für Dermatologie und Venerologie, Hauptstrasse 36a, Innere Neustadt, Dresden
Hautzentrum Dülmen
Pro Derma Hautzentrum Dülmen, Vollenstr. 8, 48249, Dülmen
Durani Cosmetics GmbH
Durani Cosmetics GmbH, Grüne Meile 56, 69115, Heidelberg
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Dermatologische Gemeinschaftspraxis Mahlow, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Hautarztpraxis Dr. Offers und Dr. Adamini
Hautarztpraxis Dr. Offers und Dr. Adamini, Gravenhorster Str. 5, 49477, Ibbenbüren
Hautarztpraxis Dr. Wilfried Steinborn
Hautarztpraxis Dr. Wilfried Steinborn, Theresienplatz 8, 94315, Straubing
Praxis Dr. Julia Reichle
Praxis Dr. Julia Reichle, Berliner Allee 96, 13088, Berlin
Studienzentrum Dr. med. Beate Schwarz Dermatologie und Allergologie
NA, Bismarckstrasse 49, 89129, Langenau
Derma Science GmbH
NA, Hohe Bleichen 10, 20354, Hamburg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-09-20 | 2025-08-25 | 2022-10-04 | 2025-08-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Germany | Acceptable 2024-08-08
|
2024-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | Germany | Acceptable | 2025-02-06 |