SCULPTURE extension study
Research type
Research Study
Full title
A multicentre, double-blind and open label, 2 year extension study of subcutaneous secukinumab in pre-filled syringes, assessing long-term safety, tolerability and efficacy in subjects with moderate to severe chronic plaque-type psoriasis treated with either a fixed dose regimen or on a retreatment at start of relapse regimen.
IRAS ID
112289
Contact name
Catherine Hatchard
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-000985-39
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
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 an extension study which will allow subjects currently enrolled in the CAIN457A2304 study to continue to receive treatment for a further two years. This study will also introduce pre-filled syringes to these patients and it is intended that patients learn to self-inject with these syringes, however administration will be done by the site staff if the subject is not able or willing to self-inject.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
12/EM/0308
Date of REC Opinion
17 Sep 2012
REC opinion
Favourable Opinion