Nasal Polyposis
Conditions
Interventions
investigational material(s)
Generic name etc : Benralizumab
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
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 or more at enrolment 7. Bi-weekly mean NBS 1.5 or more at randomization 8. SNOT-22 total score 20 or more at enrolment and randomization 9. Documented physician-diagnosed asthma 10. Blood eosinophil count of >2% or 150/microL or more at enrolment
Exclusion criteria
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: - Unilateral antrochoanal polyps - Nasal septal deviation that occludes at least one nostril - Current rhinitis medicamentosa - Allergic fungal rhinosinusitis or allergic fungal sinusitis; 3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results 4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period. 5. Receipt of any marketed or investigational biologic product within 6 months of enrolment 6. Currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics - | — |
Countries
Asia except Japan, Japan
Outcome results
None listed