Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
19
Countries
2
Sites
2
Gout flares
Key facts
- Sponsor
- Leo Pharma A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 7 Jan 2025 → 18 Sep 2025
- Decision date (initial)
- 2024-09-10
- 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
Gout flares
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10073080 | Autoinflammatory diseases | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leo Pharma A/S
- Sponsor organisation
- Leo Pharma A/S
- Address
- Industriparken 55
- City
- Ballerup
- Postcode
- 2750
- Country
- Denmark
Scientific contact point
- Organisation
- Leo Pharma A/S
- Contact name
- Global Clinical Development
Public contact point
- Organisation
- Leo Pharma A/S
- Contact name
- Global Clinical Development
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 8 | 1 |
| Netherlands | Ended | 5 | 1 |
| Rest of world
United Kingdom
|
— | 6 | — |
Investigational sites
Groupement Des Hopitaux De L'Institut Catholique De Lille
Rheumatology, 115 Rue Du Grand But, Bp 50249 Lille, Lomme Cedex
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Rheumatology Department, Tegelseweg 210, 5912 BL, Venlo
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 |
|---|---|---|---|---|---|
| France | 2025-01-07 | 2025-08-07 | 2025-01-07 | 2025-06-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Netherlands | Acceptable 2024-09-09
|
2024-09-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-09 | Netherlands | Acceptable 2024-09-09
|
2024-10-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-04 | Netherlands | Acceptable 2024-09-09
|
2025-03-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | Acceptable | 2025-04-03 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-06 | Netherlands | Acceptable | 2025-03-13 |