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
- Bacoba AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 17 Oct 2025 → 31 Mar 2026
- Decision date (initial)
- 2025-10-09
- 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
Bacoba AG
- Sponsor organisation
- Bacoba AG
- Address
- Schloss Buonas 1
- City
- Buonas
- Postcode
- 6343
- Country
- Switzerland
Scientific contact point
- Organisation
- Bacoba AG
- Contact name
- Quality and Regulatory Affairs Manager
Public contact point
- Organisation
- Bacoba AG
- Contact name
- Quality and Regulatory Affairs Manager
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
Dr. Niesmann And Dr. Othlinghaus GbR
NA, Alleestrasse 80, Innenstadt, Bochum
SRH Wald-Klinikum Gera GmbH
Zentrum für Klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera
Eurofins bioskin GmbH
Research Center dermatology, Messberg 4, Hamburg-Altstadt, Hamburg
Klinische Forschung Dresden GmbH
NA, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden
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 | 2025-10-17 | 2026-03-30 | 2025-11-10 | 2026-03-16 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Germany | Acceptable 2025-10-09
|
2025-10-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-27 | Germany | Acceptable 2025-10-09
|
2026-03-27 |