Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
2
Severe, Refractory Systemic Lupus Erythematosus
Key facts
- Sponsor
- Autolus Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 13 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-18
- 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
Severe, Refractory Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Autolus Limited
- Sponsor organisation
- Autolus Limited
- Address
- 191 Wood Lane
- City
- London
- Postcode
- W12 7FP
- Country
- United Kingdom
Scientific contact point
- Organisation
- Autolus Limited
- Contact name
- Wolfram Brugger
Public contact point
- Organisation
- Autolus Limited
- Contact name
- Wolfram Brugger
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 6 | 2 |
| Rest of world
United Kingdom
|
— | 6 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2024-06-13 | 2025-06-10 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-06 | Spain | Acceptable 2024-03-11
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-23 | Spain | Acceptable 2024-06-06
|
2024-06-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-05 | Spain | 2024-10-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-25 | Spain | Acceptable 2025-01-10
|
2025-01-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-21 | Spain | Not acceptable 2025-05-23
|
2025-05-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-29 | Spain | 2025-05-29 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-07 | Spain | 2025-07-07 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-13 | Spain | 2026-03-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-13 | Spain | Acceptable 2026-05-29
|
2026-06-01 |