A study to look at the effects of secukinumab in paediatric psoriasis
Research type
Research Study
Full title
A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis
IRAS ID
184329
Contact name
Prakash Gowda
Contact email
Sponsor organisation
Novartis Pharmaceuticals Corporation
Eudract number
2014-005663-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 17 days
Research summary
This study is in severe chronic plaque psoriasis in the paediatric popluation (from 6 to less than 18 years of age) . The treatment being evaluated is secukinumab compared to placebo and etanercept. This is the first paediatric study in psoriasis for secukinumab.
Psoriasis is a chronic relapsing inflammatory skin disease. The psychological impact of psoriasis can be particularlly traumatic to children and adolescents. A very limited number of systemic drugs for the treatment of psoriasis are approved for chuldren and there is a high medical need for controlled studies in patients less then 18 years of age.
In childhood, the use of skin creams is the first line of treatment. In more severe cases, phototherapy is added. The next step is systemic therapy and then a biologic therapy but the systemics and biologics used are often not formally approved for children.
Sekukinumab is a new biologic therapy (targetted human antibody) which has recently been approved for use in adult psoriasis for which it is very effective. It is expected that secukinumab will have the same mode of action and treatment success in children. In addition to its effetiveness, this study will also assess the long-term safety and tolerability of secukinumab in this paediatric age group.
The study will divide patients into four groups: The first will be treated with low-dose secukinumab, the second, with high dose secukinumab. The third with placebo for 12 weeks followed by secukinumab and the fourth with etanercept. For patients in the first three groups no-one will know which group they are in. The study has a four week screening period, a 12 week induction period, a fourty week maintenance period. The extension treatment period only applies to the secukinumab groups (1-3) and then continues for over 3.5 years and is followed by a 16 week follow-up.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0007
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion