Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Moderately to severely active ulcerative colitis
Key facts
- Sponsor
- Abivax
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 13 Jun 2024 → 20 Feb 2025
- Decision date (initial)
- 2024-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Moderately to severely 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
Abivax
- Sponsor organisation
- Abivax
- Address
- 7 Boulevard Haussmann
- City
- Paris
- Postcode
- 75009
- Country
- France
Scientific contact point
- Organisation
- Abivax
- Contact name
- Clinical operations
Public contact point
- Organisation
- Abivax
- Contact name
- Clinical operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 24 | 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 |
|---|---|---|---|---|---|
| France | 2024-06-13 | 2025-02-20 | 2024-06-13 | 2024-12-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-07 | France | Acceptable 2024-03-11
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-27 | France | Acceptable 2024-05-13
|
2024-05-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-04 | France | Acceptable 2024-05-13
|
2024-09-04 |