Safety and tolerability of secukinumab in 2mL Prefilled syringes
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled, 52-weeks study to demonstrate the efficacy, safety and tolerability of subcutaneous secukinumAb injections with 2 mL pre-fiLLed syringes (300 mg) in adUlt subjects with moderate to seveRE plaque psoriasis – ALLURE
IRAS ID
211114
Contact name
Sandeep Cliff
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-005170-38
Duration of Study in the UK
2 years, 11 months, 22 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 build up 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. Currently two injections of secuknumab are required and this study will assess if a 2mL prefilled syringe is as effective and safe as two 1mL prefilled syringes.
In this study suitable patients with moderate to severe plaque type psoriasis will receive secukinumab or placebo for approximately 52 weeks either in a 2mL prefilled syringe or in to 1mL syringes, during which time their psoriasis and safety will be regularly assessed. For the group allocated placebo, after 12 weeks their psoriasis will be assessed and if their psoriasis are showing no signs of improvement they will also be allocated secukinumab. The study is looking to recruit 210 patients globally with 20 patients to be recruited from the UK.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1384
Date of REC Opinion
30 Sep 2016
REC opinion
Further Information Favourable Opinion