F1RST - evaluation of early initiation of secukinumab
Research type
Research Study
Full title
Evaluation of the eFfect of early Initiation of secukinumab in systemic treatment-naïve patients with moderate to severe plaque psoriasis Requiring Systemic Treatment (FIRST)
IRAS ID
216659
Contact name
Mark Tomlinson
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2016-003592-21
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study will compare two different approaches to treating psoriasis. Psoriasis is a skin condition which affects approximately 2 in every 100 people. It causes increased production of skin cells leading to red, flaky patches of skin covered with silvery scales known as plaques. Skin cells are normally made and replaced every three to four weeks but in psoriasis this process only lasts three to seven days causing a build-up of skin cells in plaques. Psoriasis is thought to be related to a problem with the immune system. Less severe psoriasis is usually treated with creams or ultra-violet light therapy but moderate or severe psoriasis may not respond to these treatments and tablets or injections may be needed. Current guidelines recommend methotrexate or ciclosporin tablets as first choice. Methotrexate works by killing the cells in the skin which are growing too quickly and ciclosporin reduces the body’s immune reactions; they both require frequent monitoring and blood tests to check for side effects. Secukinumab is an injectable therapy known as a monoclonal antibody; it works by deactivating a specific protein in the body (called IL-17A) which is thought to cause psoriasis. We expect 148 patients with moderate/severe psoriasis who have never received tablets or injections for their psoriasis before to be treated in the study; half will be treated with secukinumab from the beginning, the other half will start treatment with methotrexate or ciclosporin but can be switched to secukinumab if they don’t achieve clear or almost clear skin after 4 months. The study aims to show which of these approaches to starting systemic treatment is better by measuring improvements in the skin condition and how it is affecting daily life. Each patient will be in the study for approximately 40 weeks. Around 40 sites across the UK will participate.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0301
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion