* EVEREST
Research type
Research Study
Full title
A randomized, double-blind, head-to-head comparison of dupilumab versus omalizumab in severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and comorbid asthma patients
IRAS ID
300783
Contact name
Isma Iqbal
Contact email
Sponsor organisation
Sanofi
Eudract number
2021-000829-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
105379, IND number; U1111-1255-4713, WHO
Duration of Study in the UK
2 years, 2 months, 22 days
Research summary
Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a serious, chronic inflammatory disease characterised by bilateral nasal polyps and rhinosinusitis, which cause a range of persistent debilitating symptoms, including loss of smell, nasal obstruction/congestion, and nasal discharge. CRSwNP is frequently associated with other important medical conditions which further contributes to disease severity and overall disease burden.
First-line treatment options for CRSwNP include intranasal corticosteroid sprays (INCS) and saline nasal irrigations to improve symptoms of the disease such as nasal obstruction. In some patients INCS show little effect in reducing nasal polyp size and improving sense of smell, the most important symptoms reported by CRSwNP patients. In addition, systemic corticosteroids are prescribed to decrease polyp size and symptom burden, but continuous treatment is not recommended due to the known serious systemic side effects. In some patients, medical management fails and therefore, functional endoscopic sinus surgery is performed to improve sino-nasal symptoms. Surgical removal of nasal polyps does not specifically target the underlying type 2 inflammation in the sinuses, leading to high rates of recurrence and revision surgery, and may not restore the sense of smell in many patients. More recently therapeutic approaches have been focused on the use of biologics which target the associated type 2 inflammation.
The purpose of this study is to evaluate whether dupilumab works better than omalizumab, two already approved biologics for the treatment of CRSwNP and asthma. The study will evaluate if there is a reduction in nasal polyps and improved sense of smell, as well as a reduction in nasal congestion, improved lung and nasal function, and improved patients’ overall quality of life. The study will last up to 40 weeks and is planned to include approximately 422 participants at approximately 100 study centers worldwide. Participants will be randomised to receive either dupilumab or omalizumab.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0264
Date of REC Opinion
26 Aug 2021
REC opinion
Further Information Favourable Opinion