Extension study of secukinumab in moderate to severe plaque psoriasis

• Research type

  Research Study

• Full title

  A multicentre, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab.

• IRAS ID

  111859

• Contact name

  James Warburton

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-000533-39

• 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 is implicated in psoriasis, psoriatic arthritis, and rheumatoid arthritis. The study is an extension study for participants completing other studies with secukinumab (termed the 'core' studies). The study will collect long-term efficacy, safety and tolerability data in either continuous or interrupted therapy (randomised withdrawal period). Participants will be in this extension study for just over 2 years. The study is looking to recruit approximately 1,220 patients worldwide into the study with up to 30 of these from the UK from 7 centres.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  12/ES/0074

• Date of REC Opinion

  7 Sep 2012

• REC opinion

  Favourable Opinion