Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

Inclusion criteria:

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

Exclusion criteria:

1. Any nasal and/or sinus surgery within 3 months prior to enrolment
2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:

1. Unilateral antrochoanal polyps
2. Nasal septal deviation that occludes at least one nostril
3. Current rhinitis medicamentosa
4. Allergic fungal rhinosinusitis or allergic fungal sinusitis;
5. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
6. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
7. Receipt of any marketed or investigational biologic product within 6 months of enrolment
8. Currently pregnant or breastfeeding