Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
62
Countries
4
Sites
14
Systemic Lupus Erythematosus
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 30 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-19
- 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
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 |
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 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
- AstraZeneca Clinical Study Information Center
Locations
4 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 15 | 7 |
| Germany | Authorised, recruiting | 7 | 3 |
| Netherlands | Authorised, recruiting | 3 | 1 |
| Spain | Ongoing, recruiting | 7 | 3 |
| Rest of world
Canada, United States, Japan, China
|
— | 30 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Nephrlogy and Immunology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Montpellier
Rheumatology, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Bordeaux
Rheumatology, Place Amelie Raba Leon, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Internal medicine, 43 Boulevard De L Hopital, 75013, Paris
Les Hopitaux Universitaires De Strasbourg
Rheumatology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
CHRU De Nancy
Internal medicine, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Assistance Publique Hopitaux De Paris
Rheumatology, 43 Boulevard De L Hopital, 75013, Paris
University Hospital Cologne AöR
Department I of Internal Medicine, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Erlangen AöR
Rheumatologie & Immunologie, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Magdeburg AöR
Hematology/Oncology, Leipziger Strasse 44, 39120, Magdeburg
Academisch Medisch Centrum
Rheumatology and Clinical Immunology, Meibergdreef 9, 1105 AZ, Amsterdam
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital De Merida
Rheumatology, Avenida De Don Antonio Campos Hoyos No 26, 06800, Merida
Hospital Universitario Rio Hortega
Internal Medicine, Calle Dulzaina 2, 47012, Valladolid
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 |
|---|---|---|---|---|---|
| France | 2025-07-11 | 2025-08-20 | |||
| Germany | 2026-04-27 | ||||
| Netherlands | 2025-11-06 | ||||
| Spain | 2025-06-30 | 2025-10-16 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Germany | Acceptable with conditions 2025-06-17
|
2025-06-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-07 | Germany | Acceptable 2026-02-23
|
2026-02-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-19 | Acceptable 2026-02-23
|
2026-03-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-04 | Germany | Acceptable 2026-02-23
|
2026-05-04 |