At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 100 mg GSK2586184, 200 mg GSK2586184, and 2 other interventions for Psoriasis. Completed, enrolled 68 participants across 15 sites in 2 countries.
Detailed 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)
Study Details
Timeline
Interventions
100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
Placebo tablets to be taken twice daily with food for up to 84 days.