Advanced ENT and Allergy | Breckenridge
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About
Primary Objective
-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell
Secondary Objectives
Full description
Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.
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Inclusion criteria
Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
Participants with bilateral sino-nasal polyposis, that despite prior treatment with Systemic corticosteroids (SCS) anytime within the past 2 years; and/or medical contraindication/intolerance to SCS; and/or prior surgery for NP have:
Participants with a physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 treated with low, medium or high dose inhaled corticosteroids (ICS) and a second controller (ie, LABA), a third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before Visit 1 (screening visit) and during the screening and run-in period.
Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 or 2.
Treatment with intranasal mometasone ≥200 μg once daily (QD) (or equivalent of another INCS) for 1 month prior to Visit 1 and during the run-in period (for CRSwNP).
Eligibility as per omalizumab drug-dosing table (serum IgE level ≥30 to ≤1500 IU/mL and body weight ≥30 to ≤150 kg) and ability to be dosed per the dosing table.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
320 participants in 2 patient groups
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Central trial contact
Trial Transparency email recommended (Toll free number for US & Canada)
Data sourced from clinicaltrials.gov
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