A clinical study to evaluate secukinumab in Nail Psoriasis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, multicentre study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300mg s.c. and to assess safety, tolerability and long-term efficacy up to 80 weeks in subjects with moderate to severe nail psoriasis.
IRAS ID
126182
Contact name
Catherine Hatchard
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-005413-40
ISRCTN Number
n/a
Research summary
Psoriasis is a chronic relapsing disease of the skin characterised by variable clinical features. In many subjects suffering from psoriasis the nails of the fingers and toes are affected. Nail psoriasis has a reported lifetime incidence in psoriatic subjects of up to 90%. The involvement of the nails may have a severe impact on the quality of life, including the inability to use tools in the hands and the inability to walk without significant discomfort and pain. Psoriasis of the nails is often resistant to many kinds of therapy (topical and systemic). Biological treatments are now being investigated for psoriasis but larger, targetted studies are required for nail involvement.
Secukinumab is a new class protein based drugs ("biologics") which target and neutralise specific chemical messages involved in the disordered immune processes of psoriasis.
In this study, suitable patients with Nail Psoriasis will receive secukinumab treatment for approximately 18 months, during which their nail psoriasis and safety will be assessed regularly. The study is looking to recruit 195 patient globally, 30 from the UK.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/0666
Date of REC Opinion
16 Jul 2013
REC opinion
Further Information Favourable Opinion