Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
55
Countries
4
Sites
5
Inflammatory bowel disease (moderate to severe active ulcerative colitis)
Key facts
- Sponsor
- Enthera S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 22 Apr 2024 → 18 Aug 2025
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507340-36-00
- WHO UTN
- U1111-1295-7677
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Inflammatory bowel disease (moderate to severe active ulcerative colitis)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Enthera S.r.l.
- Sponsor organisation
- Enthera S.r.l.
- Address
- Via Uberto Visconti Di Modrone 18
- City
- Milan
- Postcode
- 20122
- Country
- Italy
Scientific contact point
- Organisation
- Enthera S.r.l.
- Contact name
- Filippo Canducci
Public contact point
- Organisation
- Enthera S.r.l.
- Contact name
- Lisa Maria Olson
Locations
4 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 10 | 2 |
| Hungary | Ended | 10 | 1 |
| Netherlands | Ended | 10 | 1 |
| Romania | Ended | 10 | 1 |
| Rest of world
Moldova, Republic of, Georgia
|
— | 15 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
3501: Internal Diseases Department, Bulevard Bilgariya 104, 1404, Sofiya
Diagnostics And Consultation Center Convex Ltd.
3502:NA, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Universitair Medisch Centrum Utrecht
3101: Gastroenterology, Heidelberglaan 100, 3584 CX, Utrecht
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-04-22 | 2025-04-16 | 2024-04-22 | 2025-03-05 | |
| Hungary | 2024-11-27 | 2025-04-01 | 2024-11-27 | 2025-03-05 | |
| Romania | 2024-07-19 | 2025-05-14 | 2024-07-19 | 2025-03-05 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-15 | Netherlands | Acceptable with conditions 2024-03-18
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-26 | Acceptable with conditions | 2024-05-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-21 | Netherlands | 2024-05-21 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-24 | 2024-05-24 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-29 | 2024-05-29 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Netherlands | Acceptable 2024-07-25
|
2024-07-25 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-09-26 | Netherlands | Acceptable 2024-07-25
|
2024-09-26 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-09-27 | Acceptable 2024-07-25
|
2024-09-27 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-30 | Netherlands | Acceptable 2024-11-27
|
2024-11-29 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-12-09 | Acceptable 2024-11-27
|
2024-12-09 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-04-16 | Acceptable 2024-11-27
|
2025-04-16 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-09 | No conclusion 2025-06-23
|
2025-07-07 |