Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
2
Sites
3
Dermatitis atopic
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 20 Nov 2024 → 2 Apr 2026
- Decision date (initial)
- 2025-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513495-17-00
- WHO UTN
- U1111-1303-3406
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Dermatitis atopic
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012438 | Dermatitis atopic | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 10 | 2 |
| Germany | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-11-20 | 2026-04-02 | 2024-11-20 | 2025-05-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Germany | Acceptable 2024-10-30
|
2024-11-01 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-11-29 | Acceptable 2024-10-30
|
2025-03-11 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Germany | Acceptable | 2025-05-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-11 | Germany | Acceptable 2025-09-08
|
2025-09-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-24 | Germany | Acceptable 2026-03-23
|
2026-03-24 |