Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
25
Countries
3
Sites
12
Active Ulcerative Colitis (UC)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-05-20
- 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
Active Ulcerative Colitis (UC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 3 | 2 |
| Germany | Authorised, recruitment pending | 2 | 1 |
| Poland | Authorised, recruitment pending | 14 | 9 |
| Rest of world
United Kingdom, United States
|
— | 6 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Gastro-Enterology, Deltalaan 1, 8800, Roeselare
UZ Leuven
Gastro-Enterology, Herestraat 49, 3000, Leuven
Manermed Sp. z o.o.
NA, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorób Wewnętrznych i Gastroenterologii, Ul. Woloska 137, 02-507, Warsaw
Amicare Sp. z o.o. S.K.
S.K. Amicare centrum medyczne Oddział Łódź, Ul. Zgierska 249, 91-495, Lodz
Allmedica Badania Kliniczne Sp. z o.o. sp.k.
NA, Ul. Kowaniec 2a, 34-400, Nowy Targ
Medrise Sp. z o.o.
NA, Ul. Onyksowa 10, 20-582, Lublin
Planetmed Sp. z o.o.
NA, Ul. Lubinowa 12/8, 52-210, Wroclaw
Medical Network Sp. z o.o.
WIP IBD Point Jarosław Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Eskulap Pabianice Sp. z o.o.
NA, Ul. Grobelna 8, 95-200, Pabianice
Solumed Sp. z o.o. sp.k.
NA, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-26 | Poland | Acceptable 2026-05-18
|
2026-05-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Poland | Acceptable 2026-05-18
|
2026-05-28 |