secukinumab in patients with mod to sev chronic plaque-type psoriasis

• Research type

  Research Study

• Full title

  A randomised, double-blind, double-dummy, placebo controlled, multicentre study of subcutaneous secukinumab to demonstrate efficacy after 12 weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long term efficacy up to one year in patients with moderate to severe chronic plaque-type psoriasis.

• IRAS ID

  64443

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-022228-66

• ISRCTN Number

  na

• Research summary

  Psoriasis is a common skin condition affecting 2-3% of the population of the United Kingdom and Ireland. The cause of psoriasis is not fully known however there is significant evidence demonstrating a disorder of the immune system which causes new skin cells to be produced faster than normal. Skin cells usually take about 21-28 days to replace themselves; in psoriasis this process is greatly accelerated, and skin cells can be replaced every 2-6 days. This results in a build up of skin cells on the surface of the skin, in the form of a psoriatic plaque (white scaly area). There are various treatments that are used for Psoriasis ranging from topical creams (applied directly to the skin), Phototherapy (treatment with ultraviolet light), systemic treatment (oral tablets) to Biological treatment (injections given for those patients who do not respond to any other treatments listed above). Biologics are protein based drugs which target and neutralise specific chemical messengers involved in the disordered immune processes of psoriasis. Secukinumab is a new class of biologic, and is an antibody directed against one of the chemical messengers that's implicated in psoriasis, psoriatic arthritis, and rheumatoid arthritis.The study is split into 4 stages, screening, induction, maintenance and a treatment free follow up period. The participant will be in the study for a maximum of 68 weeks, with up to 52 weeks on study treatment). The study is looking to recruit approximately 1,264 patients worldwide into the study with 25 of these from the UK from 5 centres.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0167

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion