Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
9
Countries
1
Sites
1
Crohn’s fistula
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 13 Mar 2025 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Crohn’s fistula
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- principal investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research project manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Chirurgie digestive, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
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 | 2025-03-13 | 2025-03-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | France | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-14 | France | Acceptable 2025-02-28
|
2025-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-06 | France | Acceptable 2025-07-07
|
2025-07-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-16 | France | Acceptable 2026-02-02
|
2026-02-02 |