A Phase 3 interventional study of GSK2894512 1% cream and Vehicle cream in Psoriasis, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
Browse Psoriasis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male or female. A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion Criteria:
Concurrent conditions and history of other diseases:
Used any of the following treatments within the indicated period before the Baseline visit:
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
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
1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.
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
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.
Time frame: Baseline (Day 1) and Week 12
Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline 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.
Time frame: Baseline (Day 1) and up to Week 12
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
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.
Time frame: Baseline (Day 1) and up to Week 12
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline