A Study to Evaluate the Safety, Mode of Action and Clinical Efficacy of GSK3050002 in Subjects With Psoriatic Arthritis
Status:
Withdrawn
Trial end date:
2019-08-09
Target enrollment:
Participant gender:
Summary
Chemokine (C-C motif) ligand 20 (CCL20) is a protein involved in attracting immune cells
including subsets of T cells (for example Th17 cells), B cells, natural killer cells and
dendritic cells to inflamed tissues in conditions such as psoriasis (Ps) and psoriatic
arthritis (PsA). CCL20 acts by binding and activating the chemokine receptor 6 (CCR6) present
on the surface of the inflammatory cells. Levels of CCL20 are increased in inflamed tissues
in psoriasis (Ps) and inflammatory arthritis. GSK3050002 is a humanized Immunoglobulin G
(Ig)G monoclonal antibody, which binds to and neutralizes the action of human CCL20. The
hypothesis is that GSK3050002 will reduce the movement of inflammatory cells into tissues
affected by Ps or PsA, thereby leading to an improvement in disease activity. The primary
objective of this multi-centre, randomized, double-blind (sponsor open), placebo-controlled
trial is to evaluate the safety and tolerability of repeat doses of GSK3050002, and to
understand the mechanism of action (by taking skin and synovial biopsy samples) and potential
for clinical efficacy of GSK3050002 in subjects with PsA. A minimum of 18 subjects and up to
a maximum of 30 subjects will be randomised into the study to either GSK3050002 or placebo in
a 2:1 ratio to ensure that approximately 18 evaluable subjects complete the study. The total
duration of participation in the study will be approximately 21 weeks from screening to last
study visit.