Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Moderately to severely active ulcerative colitis
Key facts
- Sponsor
- Abivax
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Sep 2024 → 14 Oct 2025
- Decision date (initial)
- 2024-08-15
- 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
Moderately to severely active ulcerative colitis
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 |
|---|---|---|---|
| Germany | Ended | 48 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-09-09 | 2025-10-14 | 2024-09-09 | 2025-09-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-17 | Germany | Acceptable 2024-08-14
|
2024-08-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-24 | Germany | Acceptable 2024-11-15
|
2024-11-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-10 | Germany | Acceptable 2024-11-15
|
2025-03-10 |