Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
207
Countries
1
Sites
1
Dermatitis atopic
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 25 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-523826-41-00
- WHO UTN
- U1111-1328-7723
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
- 13 Quai Jules Guesde
- City
- Vitry Sur Seine
- Postcode
- 94400
- 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 207 | 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 |
|---|---|---|---|---|---|
| Belgium | 2026-02-25 | 2026-02-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-04 | Belgium | Acceptable 2026-02-16
|
2026-02-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-25 | Belgium | Acceptable 2026-04-07
|
2026-04-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-22 | Belgium | Acceptable 2026-04-07
|
2026-04-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-27 | Belgium | Acceptable 2026-05-11
|
2026-05-11 |