GP15-302: Randomised Study To Compare GP2015 and Enbrel in Psoriasis
Research type
Research Study
Full title
A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis
IRAS ID
126538
Contact name
Anthony Paul Bewley
Contact email
Sponsor organisation
Hexal AG
Eudract number
2012-002011-26
Research summary
Psoriasis is a persistent relapsing disease of the skin characterised by different clinical features. Plaque-type psoriasis is the most frequent type with lesions often symmetrically distributed on the ears, elbows, knees, scalp, lower back and other areas of the body. The cause of psoriasis is unknown with evidence indicating that psoriasis is caused by the action of multiple disease genes, triggered by environmental factors. Genetic factors influence the pattern of psoriasis, severity and age of onset. Psoriasis is usually not life-threatening but the lesions can cause pain, itching, and bleeding which represents a lifelong burden for the patient.
While initial treatment of plaque-type psoriasis usually involves use of surface agents, in patients not responding to surface agents, or with more widespread disease, lighttherapy with ultraviolet (UV) B light or systemic PUVA (Psoralen plus UV light A) treatment is appropriate. Patients with more severe disease may require therapy with systemic agents as well as with biologic.
Etanercept (Enbrel®), an anti-TNF agent, has been approved as a safe and effective product for the treatment of patients with moderate to severe plaque psoriasis in the US, Europe and other countries. The sponsor has developed a biosimilar etanercept for which the code name GP2015 is used in this study.
The purpose of this study is to compare GP2015 (the study drug), to Enbrel® for treating plaque-type psoriasis. The study aims to show that GP2015 works the same way in the body as Enbrel® and to find out if GP2015 has similar benefits for the patient. The study will also evaluate the effects of repeated switching between GP2015 and Enbrel®. Additionally, in some patients, the concentrations of GP2015 and Enbrel® in the blood will be measured.
Around 370 patients in 50 to 100 study centres in approximately 12 countries will take part in this study.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/0736
Date of REC Opinion
2 Jul 2013
REC opinion
Further Information Favourable Opinion