Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
26
Countries
1
Sites
1
active arthritis, vasculitis, pulmonary sarcoidosis
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519864-42-00
- EudraCT number
- 2018-001002-29
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
active arthritis, vasculitis, pulmonary sarcoidosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Anne Roivainen
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Anne Roivainen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 26 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-23 | Finland | Acceptable 2025-01-29
|
2025-01-29 |