Open Label Extension Study of Omalizumab in CRS with Nasal Polyps
Research type
Research Study
Full title
Open-Label Extension Study of Omalizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps
IRAS ID
241592
Contact name
Carl Philpott
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2017-003450-16
Duration of Study in the UK
1 years, 5 months, 16 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, where clinical evidence strongly suggests a potential benefit of omalizumab in patients with CRSwNP.
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult patients with CRSwNP who completed the double-blind placebo-controlled Phase III Study GA39688 or GA39855. A total of approximately 240 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 52 weeks (28-week treatment period, 24-week off-treatment observation phase).
Study procedures include vital signs, physical exams, urine/blood samples, assessment of health via EQ-5D-5L questionnaire, Asthma quality of life questionnaire (asthmatics only), MOS Sleep Scale, Healthy Days Core Module, and Patient Global Impression of Change, in addition to video nasal endoscopy, and assessment of nasal symptoms via SNOT-22, UPSIT and nasal congestion score.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0121
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion