Extension study for subjects completing a dupilumab asthma study
Research type
Research Study
Full title
Open-label extension study to evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.
IRAS ID
194868
Contact name
Anita Pichori
Contact email
Sponsor organisation
Sanofi
Eudract number
2013-003856-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Liberty Asthma Traverse, Protocol name
Duration of Study in the UK
3 years, 5 months, 15 days
Research summary
This study (called Liberty Asthma Traverse) looks at the long-term safety and effectiveness of a study drug called dupilumab in people who have persistent asthma. [Persistent asthma means that subjects are not able to reduce their asthma symptoms even though they are using several asthma medicines.] Subjects taking part in this study will already have been treated in one of two previous asthma studies called Liberty Asthma Quest and Liberty Asthma Expedition. In these two studies, subjects received either dupilumab or dummy drug every two weeks on top of their usual asthma medicines. In Liberty Asthma Traverse, each subject will receive dupilumab on top of their usual asthma medicines every two weeks for up to 96 weeks. During the treatment period, subjects will come to clinic for the dupilumab injection, and at some of these visits, will be asked to complete various clinical tests and questionnaires asking about their asthma and wellbeing. For subjects willing to self-inject the dupilumab at home (having been trained to do this by the study team), there is the option to come to clinic less frequently and take home with them the pre-filled syringes containing dupilumab.
Between clinic visits, subjects will 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 treatment stopped if they are unable to tolerate any side effects. During follow up (which lasts for 16 weeks), subjects will be asked to come to clinic every four weeks for more tests.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0066
Date of REC Opinion
22 Mar 2016
REC opinion
Further Information Favourable Opinion