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

Phase 1

• Conditions: Patient with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps; MedDRA version: 20.1Level: PTClassification code: 10080060Term: Chronic rhinosinusitis with nasal polyps Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-507987-38-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

1. Female or male patients aged 18 to 75 years inclusive, 10. Blood eosinophil count of >2% or =150/µL at enrolment, 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

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 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;, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified