A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis

Summary

A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis. There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184. In both Cohorts A and B, study medication will be administered orally (as tablets), twice daily, for up to 12 weeks. Each subject will have 7 out-patient visits: Screening; Baseline \& Start of treatment; Week 2; Week 4; Week 8; Week 12; and Follow-up (Week 16)

Timeline

Start

2013-03-01

Primary completion

2014-03-01

Completion

2014-03-24

Drugs

Indications