Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
4
Plaque Psoriasis
Key facts
- Sponsor
- Sudo Biosciences Limited
- 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
- 22 Jul 2024 → 25 Apr 2025
- Decision date (initial)
- 2024-06-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Plaque Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sudo Biosciences Limited
- Sponsor organisation
- Sudo Biosciences Limited
- Address
- 3rd Floor, 1 Ashley Road 1 Ashley Road
- City
- Altrincham
- Postcode
- WA14 2DT
- Country
- United Kingdom
Scientific contact point
- Organisation
- Sudo Biosciences Limited
- Contact name
- Ian Mills
Public contact point
- Organisation
- Sudo Biosciences Limited
- Contact name
- Kejal Patel
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 15 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Klinische Forschung Schwerin GmbH
Practice, Friedrichstrasse 1, Altstadt, Schwerin
Dr. Niesmann And Dr. Othlinghaus GbR
Practice, Alleestrasse 80, Innenstadt, Bochum
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Practice, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Eurofins bioskin GmbH
Research Center Dermatology, Messberg 4, Hamburg-Altstadt, 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 | 2024-07-22 | 2024-08-05 | 2025-04-25 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Germany | Acceptable 2024-06-21
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-05 | Germany | Acceptable 2024-12-23
|
2025-01-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-24 | Germany | Acceptable 2024-12-23
|
2025-03-24 |