Study comparing dupilumab to dummy drug in subjects with nasal polyps
Research type
Research Study
Full title
A randomised, 24 week treatment double-blind, placebo controlled efficacy and safety study of dupilumab 300 mg every other week, in patients with bilateral nasal polyposis on a background therapy with intranasal corticosteroids - STUDY NUMBER: EFC14146 - 'SINUS-24'
IRAS ID
211515
Contact name
Brian Lipworth
Contact email
Sponsor organisation
Sanofi-Aventis Recherce et Developpemente
Eudract number
2015-003101-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 3 days
Research summary
This study compares (to dummy drug) the safety and effectiveness of a drug called dupilumab in people who have nasal polyps. Both treatments will be given by an injection every two weeks for 24 weeks, in addition to a corticosteroid medicine sprayed into the nose. This spray is often used by subjects with nasal polyps. Dupilumab is not yet licensed for nasal polyps but it has been used in clinical trials to treat more than 4000 subjects some of whom were healthy volunteers and the rest had nasal polyps, asthma or other conditions. This study is made up of a 4 week run-in/screening period, a 24-week treatment period and a 24-week follow up period. At screening, subjects sign an informed consent form then they undergo various tests and assessments to see if they can enter the study. This includes a nasal endoscopy procedure which allows the doctor to examine the nasal passages, sinuses and nasal cavity. It is done by passing a very thin tube with light source and camera through the nostrils of the subject.
If a subject is eligible for treatment, it will then be decided by chance which treatment the subject receives: dupilumab or dummy drug. There is a 1 in 2 chance that subjects will receive dupilumab. During the treatment period, subjects come to clinic fortnightly for the first 8 weeks for tests then dupilumab/placebo injections. After 8 weeks, subjects have the option to have some injections at home if they or a caregiver are happy to administer them.
Between clinic visits, subjects will complete an electronic diary daily at home. Subjects will be continually monitored and their dupilumab/placebo treatment stopped if they are unable to tolerate any side effects. During follow up, subjects will be asked to come to clinic for further tests and assessments.REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0130
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion