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.
- Conditions
- Patient with Eosinophilic Chronic Rhinosinusitis with Nasal PolypsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-000267-72-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 275
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method