POLYP I – Chronic RhinoSinusitus with Nasal Polyps with Omalizumab
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF OMALIZUMAB IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS
IRAS ID
232092
Contact name
Carl Philpott
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2017-001724-22
Duration of Study in the UK
1 years, 6 months, 14 days
Research summary
Chronic rhinosinusitis with nasal polyps (CRSwNPs) is a predominantly adult disease with a prevalence estimated to be 2.1%−2.7%. It is associated with reduced quality of life (QoL) and significant morbidity, including asthma, which can be severe and refractory, particularly in those patients with aspirin exacerbated respiratory disease (AERD).
Intranasal and systemic/oral corticosteroids remain the mainstay of treatment, but many patients fail to achieve complete therapeutic benefit with these medications and resort to functional endoscopic sinus surgery (FESS) and other complex sinus surgery.
The marked local production of IgE antibodies in patients with CRSwNP appears to be functional and involved in the regulation of chronic inflammation. Omalizumab (Xolair ®) is a recombinant DNA-derived humanized IgG1 monoclonal antibody with a molecular mass of approximately 149 kilodaltons that selectively binds to human IgE. Multiple case-controlled and randomized, double-blind, placebo-controlled studies have been performed to examine the efficacy of omalizumab for the treatment of nasal polyps, wherein the collective and cumulative clinical evidence strongly suggests a potential benefit of omalizumab in patients with CRSwNP.
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with CRSwNP who have had an inadequate response to standard-of-care treatments. A total of approximately 120 patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (CS) therapy will be enrolled. Each patient will be followed for up to 33 weeks (5-week screening/run-in period, 24-week treatment period, 4-week off-drug safety follow-up period).
Study procedures include vital signs, physical exams, ECG, urine/blood samples, assessment of health via EQ-5D-5L questionnaire and Asthma quality of life questionnaire (asthmatics only), in addition to video nasal endoscopy, and assessment of nasal symptoms via SNOT-22, UPSIT and nasal congestion score.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/2052
Date of REC Opinion
21 Dec 2017
REC opinion
Favourable Opinion