Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
1
Primary Cold Agglutinin Disease (CAD)
Key facts
- Sponsor
- Annexon Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Jun 2024 → 5 Dec 2025
- Decision date (initial)
- 2023-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary Cold Agglutinin Disease (CAD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10068863 | Cold agglutinin disease | 10005329 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Annexon Inc.
- Sponsor organisation
- Annexon Inc.
- Address
- 1400 Sierra Point Parkway
- City
- Brisbane
- Postcode
- 94005-1808
- Country
- United States
Scientific contact point
- Organisation
- Annexon Inc.
- Contact name
- Medical Monitor
Public contact point
- Organisation
- Annexon Inc.
- Contact name
- Regulatory Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 10 | 1 |
| Rest of world
Bangladesh
|
— | 5 | — |
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 |
|---|---|---|---|---|---|
| Austria | 2024-06-17 | 2025-12-05 | 2024-07-10 | 2025-12-05 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-28 | Austria | Acceptable 2023-11-06
|
2023-11-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-25 | Austria | Acceptable 2024-03-18
|
2024-03-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-12 | Austria | Acceptable 2024-06-17
|
2024-06-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-01 | Austria | Acceptable 2024-06-17
|
2024-07-01 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-19 | Austria | Acceptable 2024-06-17
|
2024-08-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-10-10 | Austria | Acceptable 2024-06-17
|
2024-10-10 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-11-08 | Austria | Acceptable 2024-06-17
|
2024-11-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-24 | Austria | Acceptable 2025-07-16
|
2025-07-21 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-08-28 | Austria | Acceptable 2025-07-16
|
2025-08-28 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-26 | Austria | Acceptable 2025-07-16
|
2025-09-26 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-29 | Austria | Acceptable 2025-11-04
|
2025-11-10 |