Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
48
Countries
3
Sites
11
Systemic Lupus Erythematosus
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 24 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522273-10-00
- ClinicalTrials.gov
- NCT07201558
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 5 | 4 |
| Germany | Authorised, recruiting | 5 | 4 |
| Spain | Authorised, recruiting | 5 | 3 |
| Rest of world
United States, Australia, Taiwan, China, Brazil, Ukraine, United Kingdom
|
— | 33 | — |
Investigational sites
Ziekenhuis Aan De Stroom
Department of rheumatology, Lange Bremstraat 70, 2170, Antwerp
Universitair Ziekenhuis Antwerpen
Department of immunology, allergology and rheumatology, Drie Eikenstraat 655, 2650, Edegem
Centre hospitalier universitaire de Liege
Department of rheumatology, Avenue De L'Hopital 1, 4000, Liege
Ziekenhuis Aan De Stroom
Department of rheumatology, Kempenstraat 100, 2030, Antwerp
Universitaetsklinikum Bonn AöR
Rheumatology, Venusberg-Campus 1, Venusberg, Bonn
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik IV Sektion Rheumatologie und klinische Immunologie–Studienambu, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin III Rheumazentrum (G-BA-Kriterien) sowie Sektion Rheumatologie und Osteol, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Med. Klinik und Poliklinik Nephrology, Langenbeckstrasse 1, Oberstadt, Mainz
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 |
|---|---|---|---|---|---|
| Belgium | 2026-03-27 | ||||
| Germany | 2026-04-24 | ||||
| Spain | 2026-02-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | Spain | Acceptable 2026-02-02
|
2026-02-03 |