Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
45
Countries
5
Sites
13
Systemic Lupus Erythematosus
Key facts
- Sponsor
- 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]
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
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
5 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 2 | 2 |
| Germany | Authorised, recruitment pending | 6 | 3 |
| Italy | Authorised, recruitment pending | 2 | 2 |
| Poland | Authorised, recruitment pending | 4 | 3 |
| Spain | Authorised, recruitment pending | 4 | 3 |
| Rest of world
Argentina, Panama, Brazil, United States, Japan
|
— | 27 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Service de Médecine Interne et Immunologie Clinique, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Universitaire De Toulouse
Medecine interne et immunologie Clinique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin III, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Koeln AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Humanitas Mirasole S.p.A.
Unità di Fase I, Via Alessandro Manzoni 56, 20089, Rozzano
University Hospital Of Ferrara
Unità Clinica di Fase 1 Oncologia-Reumatologia, Via Aldo Moro 8, 44124, Ferrara
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Klinika Wczesnego Zapalenia Stawow, Ul. Spartanska 1, 02-637, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Reumatologii, Immunologii i Chorob Wewnetrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Uniwersytecki Szpital Kliniczny W Poznaniu
Osrodek Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-14 | Spain | Acceptable 2026-03-23
|
2026-03-23 |