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NCT02564042 · ClinicalTrials.gov registry record · Phase 2
A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 227
- Enrollment target
NCT02564042: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02564042 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 227 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564042, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 227 participants
- Enrollment target
Study 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 subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis 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 adult males and females subjects with plaque psoriasis 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.
Primary Outcome
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Mod
Interventions
- DRUG Vehicle cream
- DRUG GSK2894512 1% Cream
- DRUG GSK2894512 0.5% Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2015-11-23 |
| Est. Completion | 2016-10-05 |
| Phase | Phase 2 |
What the finished NCT02564042 record still lists
NCT02564042 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle cream is the first listed.
NCT02564042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02564042 about?
NCT02564042 is a clinical study titled "A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis". 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 subjects with plaque psoriasis. Results from this study will be considered when selecting th...
What is the current status of trial NCT02564042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2015-11-23. Estimated completion is 2016-10-05.
What interventions are being tested in trial NCT02564042?
The interventions under investigation include: Vehicle cream (DRUG), GSK2894512 1% Cream (DRUG), GSK2894512 0.5% Cream (DRUG).
Who is sponsoring clinical trial NCT02564042?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02564042's enrollment target sits among peer trials
227 265th of 2000 higher than 1,734 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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