Comparison of dupilumab to dummy drug when added to asthma treatment
Research type
Research Study
Full title
A randomised, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of dupilumab in patients with persistent asthma
IRAS ID
179158
Contact name
Anita Pichori
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2014-004940-36
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
RESP3821, NIHR CRN reference number (study is fully supported by CRN)
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This study compares the safety and effectiveness of two doses of a drug called dupilumab to a dummy drug (placebo) in adult subjects with persistent asthma. Persistent asthma means that subjects are not able to reduce their asthma symptoms despite taking multiple asthma medicines. In this study, subjects continue to take their asthma medicines and added to this, they will have injections of either dupilumab or placebo every two weeks for a year. Dupilumab has not yet been licensed for asthma but it has been used in clinical trials to treat >1000 subjects with asthma, nasal polyps or atopic dermatitis.
The duration of this study is 69 weeks and is made up of three periods: screening (4 to 5 weeks), treatment (52 weeks) and follow up (12 weeks). At screening, a subject who meets all entry criteria and consents to taking part will undergo a physical examination, blood tests, a chest x-ray, a heart function test, breathing tests, and will be asked to complete some questionnaires asking about their asthma and wellbeing. The subject will then be randomised (like the toss of a coin) to either dupilumab or dummy drug. During treatment, the subject will come to clinic for fortnightly injections and tests (breathing tests, blood tests, questionnaires etc.). Between clinic visits, subjects will be requested to complete an electronic diary and carry out a breathing test in the morning and evening daily at home. Subjects will be continually monitored and their dupilumab/placebo treatment stopped if they are unable to tolerate any side effects. Globally, 1,683 subjects are to be treated with 30 being treated in the UK. Eligible subjects who complete the treatment period and have managed to take >80% of the study drug/placebo may be offered the chance to participate in a separate study where everyone receives dupilumab.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0239
Date of REC Opinion
20 Jul 2015
REC opinion
Further Information Favourable Opinion