The CIMPACT Study
Research type
Research Study
Full title
A Phase 3, Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-and Active-Controlled Study followed by a Placebo-Controlled Maintenance Period and Open-Label Follow up to Evaluate the Efficacy and Safety of Certolizumab Pegolin in Subjects with Moderate to Severe Chronic Plaque Psoriasis
IRAS ID
168758
Contact name
John Foerster
Contact email
Sponsor organisation
UCB Biopharma
Eudract number
2014-003492-36
Clinicaltrials.gov Identifier
100348, Investigational New Drug Application (IND Number)
Duration of Study in the UK
4 years, 2 months, 5 days
Research summary
The purpose of this trial is to investigate the efficacy and safety of two dose levels of certolizumab pegol in subjects with moderate to severe chronic plaque psoriasis. Certolizumab pegol will be compared to placebo (a solution that contains no drug) and to etanercept,a drug currently approved to treat psoriasis.
Certolizumab pegol is an “anti-TNF humanised antibody”, which is a protein involved in fighting infections. It works by blocking a naturally occurring substance in the body called tumour necrosis factor. Tumour necrosis factor plays an important role in different inflammatory diseases, like psoriasis.
Etanercept (Enbrel®) is a protein that works in a similar way to certolizumab pegol by blocking the tumour necrosis factor receptor and thereby plays a role in managing diseases such as psoriasis.
Enbrel can be used to treat rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis and is approved in many countries, including Canada, the European Union, and the United States.
This trial will involve approximately 540 psoriasis subjects across approximately 50 centres throughout Central and Western Europe and North America.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0034
Date of REC Opinion
12 Mar 2015
REC opinion
Further Information Favourable Opinion