MBCT206 A Phase IIa, two-part, randomised, study for adults with COPD
Research type
Research Study
Full title
A Phase IIa, two-part, randomised, multi-centre, multinational, double blind, placebo controlled, parallel group study to compare the efficacy and safety of BCT197 when added on to standard of care for the treatment of acute respiratory exacerbations of chronic obstructive pulmonary disease (COPD) requiring hospitalisation in adults
IRAS ID
197397
Contact name
Jadwiga Anna Wedzicha
Contact email
Sponsor organisation
Mereo BioPharma 1 Ltd
Eudract number
2015-004631-13
Duration of Study in the UK
1 years, 11 months, 0 days
Research summary
This is a two-part, randomised, double-blind, placebo-controlled, study of 26 weeks duration in adult patients with acute respiratory exacerbation in Chronic obstructive pulmonary disease (COPD). COPD is a progressive condition that is a major cause of poor health and death worldwide and contributes significantly to health care costs and comorbidity. This study aims to evaluate the efficacy and safety of a new compound, named BCT197, when added on to the standard of care for the treatment of acute respiratory exacerbation of adult patients with Chronic obstructive pulmonary disease (COPD), requiring hospitalization.
BCT197 is an inhibitor of an enzyme, called p38 mitogen-activated protein kinase (MAPK). This enzyme, (MAPK) is activated in a variety of inflammatory conditions, like asthma and COPD. Inhibition of p38 MAPK has been shown to block release of inflammatory mediators, and it should result in attenuation of airway inflammation seen in acute exacerbations of COPD.
It is planned that approximately 320 subjects will be screened to enrol approximately 270 subjects, and expected that approximately 255 subjects will complete the study and follow-up, from approximately 90 centres in about 8 countries worldwide.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0261
Date of REC Opinion
12 Apr 2016
REC opinion
Further Information Favourable Opinion