MORPHEO LPS16677
Research type
Research Study
Full title
A phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma
IRAS ID
286611
Contact name
Martin Knolle
Contact email
Sponsor organisation
Sanofi Aventis Recherche & Developpement
Eudract number
2020-001217-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 18 days
Research summary
The purpose of this study is to evaluate how safe dupilumab is and whether it works to improve sleep quality in patients with asthma. The prevalence of sleep disturbances in patients with uncontrolled asthma compared to controlled asthma has been demonstrated in various research programs (in patients with several and non-severe asthma) and poor sleep is often associated with worse asthma control and quality of life. The study will investigate whether dupilumab can improve the health of a patient's lungs, control their asthma symptoms, and improve their quality of life.
The study is a randomised, double blind, placebo-controlled study and is planned to include approximately 260 participants. Each participant will be involved in the study for up to 29 weeks and will attend approximately 6 visits to the research site. All participants will receive standard of care background medication throughout the study. Most participants will be expected to administer study drug at home between study visits.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0214
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion