CAEB071C2201 - Plaque Psoriasis

• Research type

  Research Study

• Full title

  A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) response as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis

• IRAS ID

  15245

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2007-007160-19

• ISRCTN Number

  N/A

• Research summary

  This is a multi-centre phase II study which means the study drug has shown promise when tested in animals and humans. The aim of this study is to find the best dose of the study drug AEB071 that can be given safely to humans with plaque psoriasis and to determine the immediate and long term side effects of the treatment. The cause of psoriasis is not fully known however there is significant evidence to suggest that it is due to an increased activity of protein kinase C which causes new skin cells to be produced faster than normal. It is these new skin cells that form the white scaly patches on the skin. AEB071 acts by blocking the activity of Protein Kinase C, thereby limiting the rate at which the new skin cells are produced. AEB071 is developed and manufactured by the company Novartis Pharmaceuticals, and is only available for use in clinical trials. AEB071 is also being developed for use in transplant patients. This trial is a double-blind, which means neither the study doctor or patient will know what treatment they are receiving. A screening period of up to four weeks is used to assess patient eligibility for the study. Patients will then be assigned to receive either 1 of the 5 doses of AEB071 or placebo (dummy medication), for 12 weeks. AEB071/placebo is to be taken orally twice a day, 2 tablets in the morning and two tablets in the evening. After the 12 week treatment period, all patients will enter the 12 week follow up period where no study medication is given but the patient is monitored every four weeks for safety and recurrence of their disease. 336 patients are to be recruited into this study worldwide, with 36 of the patients being recruited in the UK.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/56

• Date of REC Opinion

  20 May 2009

• REC opinion

  Favourable Opinion