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A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)

NCT02564055 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2017-11-20

Study results available
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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 adolescent and adult subjects with atopic dermatitis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all atopic dermatitis 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 adolescent and adult males and females subjects with atopic dermatitis 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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

GSK2894512 1% Cream

1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically

DRUG

GSK2894512 0.5% Cream

0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically

DRUG

Vehicle cream

White to off-white vehicle cream base to be applied topically

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2017-01-01
Completion
2017-01-12

Countries

  • United States
  • Canada
  • Japan

Study Locations

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Entities

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 NCT02564055 on ClinicalTrials.gov