Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Ulcerative colitis and rheumatoid a1thritis
Key facts
- Sponsor
- Abivax
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 9 Oct 2023 → 11 Sep 2024
- Decision date (initial)
- 2023-09-11
- 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
Ulcerative colitis and rheumatoid a1thritis
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 | 32 | 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 | 2023-10-09 | 2024-09-11 | 2023-10-09 | 2024-08-12 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-28 | Germany | Acceptable 2023-09-06
|
2023-09-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-21 | Germany | Acceptable 2023-09-06
|
2023-09-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-10-05 | Germany | Acceptable 2023-09-06
|
2023-10-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-10-12 | Germany | Acceptable 2023-09-06
|
2023-10-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-21 | Germany | Acceptable 2024-01-29
|
2024-02-01 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-02-05 | Germany | Acceptable 2024-01-29
|
2024-02-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-07 | Germany | Acceptable 2024-04-16
|
2024-04-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-04-30 | Germany | Acceptable 2024-04-16
|
2024-04-30 |