Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
140
Countries
1
Sites
5
Vitiligo
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- 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
- 2 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-08
- 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
Vitiligo
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10047642 | Vitiligo | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- investigator principal
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- investigator principal
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 140 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Dermatologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Universitaire De Bordeaux
Dermatologie, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Dermatologie, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire De Nice
Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Hospices Civils De Lyon
Dermatologie, 5 Place D Arsonval, 69437, Lyon Cedex 03
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 | 2024-04-02 | 2024-05-23 | 2025-12-23 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | France | Acceptable 2024-03-04
|
2024-03-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-29 | France | Acceptable 2024-03-04
|
2024-03-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-18 | France | Acceptable 2024-03-04
|
2024-04-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-11 | France | Acceptable 2024-07-08
|
2024-07-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-18 | Acceptable 2025-04-22
|
||
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-22 | France | Acceptable 2025-05-28
|
2025-07-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-15 | France | Acceptable 2025-09-02
|
2025-09-02 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-14 | France | Acceptable 2025-12-10
|
2025-12-10 |