A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis
Status:
Completed
Trial end date:
2016-10-05
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and
1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the
topical treatment in subjects with plaque psoriasis. Results from this study will be
considered when selecting the most appropriate concentration of GSK2894512 cream and dosing
frequency in future clinical safety and efficacy studies. This is a multicenter (United
States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,
6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and
1%) and a vehicle control cream will be equally randomized and evaluated following
application to all psoriasis lesions (except on the scalp) once daily (evening) or twice
daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks
screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total
duration of subject participation will be approximately 16 to 20 weeks. Approximately 270
adult males and females subjects with plaque psoriasis will be screened in order to have at
least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and
approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in
Japan to achieve at least 24 evaluable Japanese subjects.