Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
14
Countries
1
Sites
6
chronic Graft-versus-Host-Disease (cGvHD)
Key facts
- Sponsor
- Universitaetsklinikum Erlangen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-03-27
- 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
chronic Graft-versus-Host-Disease (cGvHD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10068907 | CGVHD | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Erlangen AöR
- Sponsor organisation
- Universitaetsklinikum Erlangen AöR
- Address
- Maximiliansplatz 2, Innenstadt Innenstadt
- City
- Erlangen
- Postcode
- 91054
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Prof. Dr. med. Silvia Spörl
Public contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Prof. Dr. med. Silvia Spörl
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 14 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Koeln AöR
Innere Medizin 1, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Regensburg AöR
Innere Medizin III, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Wuerzburg AöR
Innere Medizin II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5, Ulmenweg 18, Innenstadt, Erlangen
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-19 | Germany | Acceptable 2026-03-27
|
2026-03-27 |