Clinical trial • Phase I • Immunology

GSK4527363 for Systemic lupus erythematosus | Connective tissue disease-associated interstitial lung disease

Phase I trial of GSK4527363 for Systemic lupus erythematosus | Connective tissue disease-associated interstitial lung disease. 124 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus | Connective tissue disease-associated interstitial lung disease
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
24-03-2025
First CTIS Authorization Date
18-07-2025

Trial design

Phase I trial across 11 sites in Spain, Poland.

Target Sample Size
124

Recruitment

Planned Sample Size
124
Recruitment Window Months
22

Geography

Total Number Of Sites
11
Total Number Of Participants
15

Spain

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
263
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Hospital Universitario De Navarra
Department Name
Internal medicine
Contact Person Name
Patricia Fanlo Mateo
Site Name
Hospital Universitario Rio Hortega
Department Name
Internal medicine
Contact Person Name
Julia Barbado Ajo
Site Name
Hospital Universitario Basurto
Department Name
Rheumatology Dept
Contact Person Name
Maria Esther Ruiz Lucea
Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology Dept
Contact Person Name
Joan Calvet Fontova
Contact Person Email
calvet.parctauli@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Rheumatology Dept
Contact Person Name
Ivette Casafont Solé

Poland

Earliest CTIS Part Ii Submission Date
13-06-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
273
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Ośrodek Wczesnych Faz
Contact Person Name
Piotr Wiland
Contact Person Email
rnc@umw.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Reumatologii i Chorób Wewnętrznych
Contact Person Name
Otylia Kowal-Bielecka
Contact Person Email
reum@umb.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Reumatologii, Immunologii i Chorób Wewnętrznych
Contact Person Name
Mariusz Korkosz
Contact Person Email
mariusz.korkosz@uj.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Uniwersytecki Ośrodek Wczesnych Faz
Contact Person Name
Włodzimierz Samborski
Contact Person Email
ucwbk@ump.edu.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Contact Person Name
Anna Zubrzycka-Sienkiewicz
Contact Person Email
info@reumatika.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
GSK4527363

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