GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03202004|
Recruitment Status : Withdrawn (The decision not to progress the planned Phase 3 studies is a business decision based on the need to prioritise and focus resources within GSK.)
First Posted : June 28, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: GSK2894512 1% cream Drug: Vehicle cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||The investigator, study center staff, subject, and sponsor will be blinded to randomized study treatment assignments.|
|Official Title:||A Double-Blind Safety and Efficacy Study of GSK2894512 Cream Versus Vehicle in the Treatment of Adult Plaque Psoriasis|
|Estimated Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||September 28, 2018|
|Estimated Study Completion Date :||September 28, 2018|
Experimental: GSK2894512 1% cream group
Subjects will apply a thin layer of GSK2894512 1% (10 milligrams per gram [mg/g]) topical cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.
Drug: GSK2894512 1% cream
1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.
Placebo Comparator: Vehicle cream group
Subjects will apply a thin layer of vehicle cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.
Drug: Vehicle cream
Vehicle cream will be provided in tubes labeled in compliance with country requirements.
- Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12 [ Time Frame: Baseline (Day 1) and Week 12 ]PGA is a clinical tool (a 5 point scale) for assessing the current state/severity of a subject's psoriasis. It is a morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Subjects will be scored using the following categories: 0=Clear; 1=Almost clear; 2=Mild; 3=Moderate; and 4=Severe.
- Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12 [ Time Frame: Baseline (Day 1) and up to Week 12 ]The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of percent body surface area (%BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=None; 4=Severe) and the % BSA affected is scored on a 7-point scale (0=0%; 6>=90%) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease.
- Proportion OF SUBJECTS WITH>=3-POINT REDUCTION IN WEEKLY AVERAGE ITCH/PRURITUS NUMERIC RATING SCALE (NRS) FROM BASELINE TO WEEK 12 FOR SUBJECTS WITH A BASELINE SCORE >=4 [ Time Frame: Baseline (Day 1) and up to Week 12 ]The severity and bother of psoriasis-related itching, stinging, burning, pain, and scaling and impact items about the embarrassment, avoidance of activities with other people, and movement restrictions will be assessed using Psoriasis Symptom Diary. It is a 16-item electronic, daily (24-hour recall), validated assessment that measures self-reports of psoriasis symptoms and impact on functional health. Each item will be rated on a 0 to 10 NRS, with unlabeled numbers in between the labeled anchors. Higher scores indicate more severe symptoms, bother, or impact.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202004
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|