SCULPTURE study

• Research type

  Research Study

• Full title

  A randomised, double-blind, multicentre study of subcutaneous secukinumab, assessing Psoriasis Area and Severity Index (PASI) response and maintenance of response in subjects with moderate to severe chronic plaque-type psoriasis on either a fixed dose regimen or retreatment at start of relapse regimen.

• IRAS ID

  73952

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000767-27

• ISRCTN Number

  n/a

• 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 an accumulation 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 messages involved in disordered immune processes of psoriasis.Sekukinumab is a new class of biologic, and is an antibody directed against one of the chemical messages that is implicated in psoriasis, psoriatic arthritis, and rheumatoid arthritis.This 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 60 weeks(with up to 48 weeks on study treatment). The study is looking to recruit approximately 918 patients worldwide into the study with 22 of these from 5 centres in the UK.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0234

• Date of REC Opinion

  25 Jul 2011

• REC opinion

  Further Information Favourable Opinion