MedTrace Logo

GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

NCT03202004 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-12-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • Q2 Solutions

    collaborator INDUSTRY

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2018-09-28
Completion
2018-09-28
FDA Drug
Yes

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202004 on ClinicalTrials.gov