Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
45
Countries
1
Sites
4
psoriasis vulgaris
Key facts
- Sponsor
- selectION Therapeutics GmbH, selectION Therapeutics GmbH
- 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
- 12 Dec 2023 → 23 Jun 2025
- Decision date (initial)
- 2023-12-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507393-40-00
- WHO UTN
- U1111-1295-8160
- ClinicalTrials.gov
- NCT06191042
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
psoriasis vulgaris
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 20.0 | LLT | 10050576 | Psoriasis vulgaris | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
selectION Therapeutics GmbH
- Sponsor organisation
- selectION Therapeutics GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- selectION Therapeutics GmbH
- Contact name
- selectION Therapeutics GmbH Clinical Trial Information
Public contact point
- Organisation
- selectION Therapeutics GmbH
- Contact name
- selectION Therapeutics GmbH Clinical Trial Information
selectION Therapeutics GmbH
- Sponsor organisation
- selectION Therapeutics GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 45 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
n.a., Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Eurofins bioskin GmbH
n.a., Messberg 4, Hamburg-Altstadt, Hamburg
Thermalsole und Schwefelbad Bentheim GmbH
Fachabteilung Dermatologie, Am Bade 1, 48455, Bad Bentheim
Emovis GmbH
n.a., Bezirk Charlottenburg Wilmersdorf, Wilmersdorfer Strasse 79, Berlin
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 | 2023-12-12 | 2025-06-23 | 2024-01-22 | 2025-03-17 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-04 | Germany | Acceptable 2023-12-05
|
2023-12-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-12 | Germany | Acceptable 2024-05-13
|
2024-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-09 | Germany | Acceptable 2024-08-29
|
2024-09-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-10 | Germany | Acceptable 2024-10-30
|
2024-10-31 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-11-12 | Germany | Acceptable 2024-10-30
|
2024-11-12 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-17 | Germany | Acceptable 2024-10-30
|
2025-01-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-03-19 | Germany | Acceptable 2024-10-30
|
2025-03-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-05-13 | Germany | Acceptable 2024-10-30
|
2025-05-13 |