A study to evaluate the efficacy and safety of repeating dose of benralizumab administered SC versus placebo in patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps.

Korábbi kezelés

• Any nasal and/or sinus surgery within 3 months prior to enrolment
• Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.

Más betegség

• Patients with conditions that makes them non evaluable for the coprimary efficacy endpoint including but not limited to: • Unilateral antrochoanal polyps • Nasal septal deviation that occludes at least one nostril • Current rhinitis medicamentosa • Allergic fungal rhinosinusitis or allergic fungal sinusitis;

Egyéb

• Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
• Receipt of any marketed or investigational biologic product within 6 months of enrolment
• Currently pregnant or breastfeeding

• Female or male patients aged 18 to 75 years inclusive
• Blood eosinophil count of >2% or ≥150/μL at enrolment
• Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
• History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
• Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
• Ongoing symptoms for at least 12 weeks prior to enrolment
• Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
• Bi-weekly mean NBS ≥ 1.5 at randomization
• SNOT-22 total score ≥ 20 at enrolment and randomization
• Documented physician-diagnosed asthma