The effectiveness and safety of GSK2586184 in chronic plaque psoriasis

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double-blind, placebo-controlled, dose ranging study to evaluate the safety and efficacy of GSK2586184 in patients with chronic plaque psoriasis

• IRAS ID

  116210

• Contact name

  Christopher Griffiths

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-002917-20

• Research summary

  The purpose of this study is to test if 12 weeks of treatment with GSK2586184 improve the symptoms of psoriasis and whether any side effects are caused by GSK2586184. Psoriasis is a skin condition caused by inflammation. It is expected that GSK2586184, by blocking some of the substances that cause inflammation, will improve the symptoms of psoriasis. GSK2586184 is an experimental new medicine taken as a tablet. It has not yet been approved for doctors to prescribe to patients with chronic plaque psoriasis. There will be 2 groups of participants in this study, Group A and Group B. Group A will have 56 participants randomly split into 4 groups of 14 patients who will receive one of the following given twice a day for 12 weeks: ?½ 100 mg GSK2586184 ?½ 200 mg GSK2586184 ?½ 400 mg GSK2586184?½ Placebo (a dummy medicine) Group B, will have 8 participants, who will take 400 mg GSK2586184 twice a day for 12 weeks. It will take each participant up to 20 weeks to complete the study. They will have up to 7 outpatient visits. First, they will be screened for suitability. If they are suitable, they will take their assigned treatment for 12 weeks. They will have a final visit 4 weeks after they finished taking study treatment. Information about how the study treatment affects the symptoms of psoriasis and the participant's health will be collected through tests, procedures and questionnaires such as: ?½ Physical examination?½ Blood tests ?½ Urine tests ?½ Pregnancy tests ?½ Questionnaires to assess how psoriasis affects a patient??s life ?½ Photographs of plaques The study will take place at dermatology clinics in UK and Germany. GlaxoSmithKline is funding the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0785

• Date of REC Opinion

  4 Dec 2012

• REC opinion

  Further Information Favourable Opinion