Early-onset Dupilumab Effects in CRSwNP

Ki vehet részt

• Patients age 18+
• who in normal clinical practice would be a candidate for dupilumab
• with a diagnosis of CRSwNP including
• at least 2 of the following symptoms on screening:; nasal blockade/obstruction/congestion or nasal discharge; facial pain/pressure; reduction or loss of smell

Ki nem vehet részt

• prior history of immunotherapy use (including prior participation in dupilumab or other clinical trials)
• Treatment with systemic corticosteroids, monoclonal antibodies, immunosuppressive treatments or anti-IgE therapy during the past two months prior to trial participation
• Patients with conditions/concomitant diseases making them ineligible for evaluation of the primary efficacy endpoint such as: acute sinusitis/nasal infection or upper respiratory infection at day of screening or in the two weeks prior to screening, Churg-Strauss syndrome, Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, concomitant cystic fibrosis, CT scan suggestive of allergic fungal rhinosinusitis
• Patients with comorbid asthma if they had a recent asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for >24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 ug fluticasone or an equivalent inhaled corticosteroid
• CRS without polyps or another non-nasal polyposis condition
• > 80 years of age