Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
139
Countries
2
Sites
11
Systemic Lupus Erythematosus
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development 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
- 9 Sep 2025 → ongoing
- Decision date (initial)
- 2025-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514186-18-00
- ClinicalTrials.gov
- NCT06576271
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10042947 | Systemic lupus erythematosus synd | 10028395 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 8 | 6 |
| Spain | Ongoing, recruiting | 7 | 5 |
| Rest of world
Brazil, Argentina, United States, United Kingdom
|
— | 124 | — |
Investigational sites
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Ośrodek Wczesnych Faz, Ul. Borowska 211a, 50-556, Wroclaw
Medicover Integrated Clinical Services Sp. z o.o.
Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Reumatologii i Chorób Wewnętrznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Uniwersytecki Szpital Kliniczny W Poznaniu
Uniwersytecki Ośrodek Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Reumatologii, Immunologii i Chorób Wewnętrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Parc Tauli Hospital Universitari
Rheumatology Dept, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario Rio Hortega
Internal medicine, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitario Basurto
Rheumatology Dept, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario De Navarra
Internal medicine, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Germans Trias I Pujol
Rheumatology Dept, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Poland | 2025-10-09 | 2025-10-09 | |||
| Spain | 2025-09-09 | 2025-09-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-24 | Spain | Acceptable 2025-07-14
|
2025-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-24 | Spain | Acceptable 2025-12-02
|
2025-12-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-29 | Spain | Acceptable 2026-03-10
|
2026-03-13 |