drugset / Trial / NCT03004846

A Study of GSK2981278 Ointment in Subjects With Plaque Psoriasis

NCT03004846

Phase 1/2 Completed 8 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR) gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be conducted in two parts. Part A will be an open-label, single arm study and part B will be a double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8 adult subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be enrolled. Total duration of study will be approximately 14 weeks. The results of this study will provide preliminary information about safety and efficacy of the drug and will help in providing the guidance for further development strategy.

Timeline

Start
2017-02-13
Primary completion
2017-05-05
Completion
2017-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2981278 Small molecule 0.8 % Topical
Subject GSK2981278 Small molecule 2 % Topical
Subject GSK2981278 Small molecule 4 % Topical

Indications