Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
2
Anal or recto-cutaneous or recto-vaginal Crohn-related fistula
Key facts
- Sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 21 Apr 2026 → ongoing
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518898-34-00
- EudraCT number
- 2022-003197-23
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Anal or recto-cutaneous or recto-vaginal Crohn-related fistula
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002156 | Anal fistula | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uniwersytet Jagiellonski Collegium Medicum
- Sponsor organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Address
- Ul. Sw. Anny 12
- City
- Cracow
- Postcode
- 31-008
- Country
- Poland
Scientific contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Principal Investigator/Piotr Wałęga
Public contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Jagiellońskie Centrum Wsparcia Badań Klinicznych
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 48 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie
Klinika Chirurgii Ogólnej i Onkologicznej, Ul. Wroclawska 1/3, 30-006, Cracow
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Kliniczny Chirurgii Ogólnej i Onkologii, Os. Zlotej Jesieni 1, 31-826, Cracow
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 |
|---|---|---|---|---|---|
| Poland | 2026-04-21 | 2026-05-12 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-22 | Poland | Acceptable with conditions 2025-01-30
|
2025-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-05 | Poland | Acceptable 2025-10-02
|
2025-10-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-11 | Poland | Acceptable 2025-10-02
|
2026-03-11 |