Psoriasis Clinical Trial
Official title:
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
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)
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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