Secukinumab in treatment of chronic palmoplantar pustular psoriasis
Research type
Research Study
Full title
A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis.
IRAS ID
136458
Contact name
Catherine Hatchard
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-003086-34
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Psoriasis is a long lasting disease that appears on the skin. A relatively rare manifestation or sub-group of psoriasis is palmoplantar pustular psoriasis, which accounts for less than 5% of all psoriasis cases. Pustular psoriasis lesions confined to the palms and soles is known as palmoplantar pustular psoriasis (pppp). 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, including the palms and soles. 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 skin cells.
In this study we are using a drug called secukinumab, this is a new class of protein based drug (“biologics“) which target and neutralise specific chemical messages involved in the disordered immune processes of psoriasis.
In this study suitable patients with palmoplantar pustular plaque psoriasis will receive secukinumab or placebo for approximately 52 weeks, during which time their palmoplantar pustular plaque psoriasis and safety will be regularly assessed. For the group allocated placebo, after 16 weeks if they are showing no signs of improvement they will also be allocated secukinumab. The study is looking to recruit 210 patients globally with 50 patients to be recruited from the UK.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0558
Date of REC Opinion
12 Dec 2013
REC opinion
Further Information Favourable Opinion