Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
18
Countries
1
Sites
2
Systemic Lupus Erythematosus (SLE)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 27 Oct 2022 → 18 Dec 2024
- Decision date (initial)
- 2024-06-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509188-26-00
- EudraCT number
- 2021-001565-20
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus (SLE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 7 | 2 |
| Rest of world
United States, Moldova, Republic of
|
— | 11 | — |
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 |
|---|---|---|---|---|---|
| Poland | 2022-10-27 | 2024-12-17 | 2023-01-30 | 2023-11-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-27 | Poland | Acceptable 2024-06-21
|
2024-06-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-20 | Poland | Acceptable 2024-06-21
|
2024-11-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-02 | Poland | Acceptable 2025-02-03
|
2025-02-10 |