NCT03202004

GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

A Double-Blind Safety and Efficacy Study of GSK2894512 Cream Versus Vehicle in the Treatment of Adult Plaque Psoriasis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of GSK2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized, double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis. The aim of this study is to show superiority of GSK2894512 over vehicle by comparing their response rates. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks blinded treatment, and 1 week post-treatment follow-up period. Subjects will apply randomized study treatment to all psoriasis lesions once daily for 12 weeks. Subjects will be stratified by Baseline physician global assessment (PGA) category (PGA score=2, PGA score \>=3) at randomization. Approximately 120 subjects will be randomized into the study of which 80 will receive GSK2894512 1% cream and 40 will receive vehicle cream. Total duration of a subject's participation in the study will be approximately for 14 to 17 weeks.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GSK2894512 1% cream	1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.
DRUG	Vehicle cream	Vehicle cream will be provided in tubes labeled in compliance with country requirements.

Timeline

• Start date: 2018-01-22
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2017-06-28
• Last updated: 2017-12-07

Regulatory

• FDA-regulated drug study