CAIN457A3302 - OPTIMISE STUDY
Research type
Research Study
Full title
Long term clear skin maintenance treatment optimization in patients with moderate to severe chronic plaque psoriasis: A randomized, multicenter, open-label with blinded-assessment, comparative, 52 week study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg s.c.
IRAS ID
173722
Contact name
Professor Christopher Griffiths
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-005339-15
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Psoriasis is a long lasting disease that appears on the skin. It results in patches of thick, red, raised skin covered with silvery white buildup of dead skin cells called scales. These patches, which are referred to as plaques, may itch or feel sore. They can occur on any part of the body. Some patients with plaque-type psoriasis may have joint inflammation, a condition commonly known as psoriatic arthritis. The cause of psoriasis is not fully understood. It is believed that psoriasis occurs when the immune system sends out faulty signals that speed up the growth cycle of the skin cells. Secukinumab is a drug which alters the function of the immune system and, at the dose of 300mg, has been shown in previous studies to be effective in the treatment of psoriasis. After an initial induction period of 4 weeks, where secukinumab is given on a weekly basis, the treatment then needs to be given over a long term period so that the psoriasis does not re-appear; usually this is given every 4 weeks. The aim of this study is to find out if patients who initially respond to secukinumab with clearing or almost clearing of skin lesions would benefit from longer intervals between injections and if patients who initially show improvement but without clearing or almost clearing of skin lesions would benefit from more frequent treatment with secukinumab.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0443
Date of REC Opinion
9 Sep 2015
REC opinion
Further Information Favourable Opinion