SIGNATURE Study CAIN457AGB01
Research type
Research Study
Full title
Secukinumab In patients with moderate to severe active, chronic plaque psoriasis who have failed on TNFa antaGoNists: A clinical Trial EvalUating Treatment REsults (SIGNATURE)
IRAS ID
133773
Contact name
Richard Warren
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2013-001855-11
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). \n\nThere 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.\nSekukinumab 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.\n\nThis study is designed to assess whether secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to one or more previous biologic (specifially anti-TNFα therapy) treatments in a UK (and Republic of Ireland) specific population. It is intended that patients will learn to self-inject with prefilled syringes of secukinumab, however administration will be done by the site staff if the subject is not able or willing to self-inject. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0241
Date of REC Opinion
6 Sep 2013
REC opinion
Further Information Favourable Opinion