A study of GSK3050002 in subjects with psoriatic arthritis (PsA).
Research type
Research Study
Full title
A multi-centre, randomised, double-blind (sponsor open), placebo-controlled, repeat dose, proof of mechanism study to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of GSK3050002 in subjects with psoriatic arthritis.
IRAS ID
188896
Contact name
Peter Taylor
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-000908-26
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Psoriatic Arthritis (PsA) is a chronic, inflammatory, disease of the joints that develops in some people with the skin condition psoriasis. It typically causes affected joints to become inflamed (swollen), stiff and painful.
GlaxoSmithKline (GSK) is developing a new medicine GSK3050002 which is a humanised (a type of protein that is engineered to resemble a human protein) monoclonal antibody which blocks the activity of a substance in the body called human CCL20. CCL20 is a small protein (called a chemokine). CCL20 is the only chemokine that attaches to a specific chemokine receptor called CCR6. CCR6 is present on some types of white blood cells. CCL20 is involved in attracting white blood cells to diseased parts of the body. Blocking CCL20 may help medical conditions related to immunity.
This is a clinical study to evaluate the safety of GSK3050002 in subjects with psoriatic arthritis (PsA). In addition, the blood levels and effects of GSK3050002 will be measured to see how well it works in treating psoriatic arthritis. Approximately 30 subjects will be recruited within Europe with 6-8 subjects from the UK
The study will be comparing GSK3050002 and a placebo which is a dummy drug made with salty water called saline. During the treatment period, subjects will be administered either GSK3050002 or placebo IV infusions at Day 1, Day 15 and Day 29 (total of 3 doses). Anticipated study duration will be approximately 21 weeks with 11 study visits.
Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0602
Date of REC Opinion
17 Nov 2015
REC opinion
Further Information Favourable Opinion