ETA304-RaPsOdy
Research type
Research Study
Full title
A Double-Blind, Randomized, Parallel-Group, Active Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel ® in Subjects With Chronic Plaque Psoriasis (CHS-0214-04) (RaPsOdy)
IRAS ID
157155
Contact name
Barbara Finck
Contact email
Sponsor organisation
Coherus Biosciences, Inc
Eudract number
2014-000444-14
Clinicaltrials.gov Identifier
Research summary
Plaque psoriasis (Pso) is a chronic (long-lasting) inflammatory skin condition, caused by an overactive immune system. This causes skin cells to grow faster than normal. Instead of shedding, these skin cells form red, raised patches of skin, called plaques. There is no cure for Psoriasis. Current therapies include topical treatment, such as vitamin D, corticosteroids or phototherapy (exposing affected areas to ultraviolet light).
In the most severe cases, systemic treatments are used. These are oral or injected medicines that work throughout the whole body.
ENBREL is a systemic treatment. It’s a medication classed as a biologic. By working on the immune system, biologics block proteins that contribute to the disease process.
Biologic drugs are manufactured in cultured cells and vary depending on culture conditions. These variations mean biologic drugs cannot be considered ‘identical’ but may be considered biosimilar.
This study will compare the effectiveness and safety of a biosimilar investigational drug developed by Coherus Biosciences, Inc. (CHS-0214) and an approved reference drug, Enbrel (EU) in patients with chronic plaque psoriasis.
This is a double blind, randomised active control study meaning that neither the participant nor the study doctor will know which medication is being given and that no participant will receive a placebo (a drug that has no medical effect)
Adult patients with Psoriasis who have never taken a systemic therapy will be randomised to one of two groups
Part 1: CHS-0214 50mg subcutaneously or Enbrel (EU) 50mg subcutaneously twice a week for 12 weeks
Part 2: Participants will continue in same groups as Part 1 but dose of the drug will be reduced to 50mg once a week for 13-48 weeks
This is a multicenter study which will take place across Australia, Canada, Chile, Israel, Russia, South Africa, Europe and USA.
It is anticipated that approximately 424 patients will be recruited worldwide.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1139
Date of REC Opinion
14 Oct 2014
REC opinion
Further Information Favourable Opinion