A study to test the safety and efficacy of GSK2269557 in APDS patients
Research type
Research Study
Full title
An open-label, single arm study to investigate the safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled GSK2269557 in patients with APDS/PASLI
IRAS ID
190832
Contact name
Edward Banham-Hall
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2015-004876-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 15 days
Research summary
This is a multi-center, non-randomised, open-label, uncontrolled, single group study to investigate the safety and pharmacokinetics (PK) during 84 days repeat dosing treatment with 1000 micrograms (mcg) of inhaled GSK2269557 in addition to standard of care, in subjects with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI). To date GSK2269557 has been administered to healthy subjects (smokers and non smokers), subjects with: stable Chronic Obstructive Pulmonary Disease (COPD); subjects experiencing a COPD exacerbation; and subjects with persistent, uncontrolled asthma. As this study is the first administration of GSK2269557 to subjects with APDS, this study will provide safety, tolerability, efficacy and pharmacokinetic data in this patient population. Up to 20 subjects will be enrolled into the study. The total duration of the study is approximately 30 weeks, including pre-screening/screening and follow-up.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0016
Date of REC Opinion
28 Mar 2016
REC opinion
Further Information Favourable Opinion