Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
4
Refractory systemic lupus erythematosus (SLE)
Key facts
- Sponsor
- Miltenyi Biomedicine GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 12 Aug 2024 → ongoing
- Decision date (initial)
- 2023-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507654-33-00
- EudraCT number
- 2022-003137-19
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory 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
Miltenyi Biomedicine GmbH
- Sponsor organisation
- Miltenyi Biomedicine GmbH
- Address
- Friedrich-Ebert-Strasse 68, Moitzfeld Moitzfeld
- City
- Bergisch Gladbach
- Postcode
- 51429
- Country
- Germany
Scientific contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Public contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 30 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Otto Von Guericke Universitaet Magdeburg
Zentrum für Innere Medizin Universitätsklinik für Hämatologie und Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Tuebingen AöR
Innere Medizin II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 3, Ulmenweg 18, Innenstadt, Erlangen
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 | 2024-08-12 | 2024-10-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-04 | Germany | Acceptable 2023-10-17
|
2023-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-24 | Germany | Acceptable 2024-07-02
|
2024-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-06 | Germany | Acceptable 2026-03-24
|
2026-03-25 |