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 PolypsMedDRA version: 20.1Level: PTClassification code 10080060Term: Chronic rhinosinusitis with nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-000267-72-IT
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 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
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of benralizumab on nasal polyp burden (assessed by nasal endoscopy) and patient-reported nasal blockage (NB).;Secondary Objective: To evaluate the effect of benralizumab on:<br>• Sense of Smell<br>• Sinus Opacification by computed tomography (CT) scan<br>• Disease specific health-related quality of life (HRQoL)<br>• Nasal polyp surgery<br>• Systemic corticosteroid (SCS) use<br>• Symptoms associated with CRSwNP;Primary end point(s): Change form baseline in endoscopic total nasal polyp score (NPS)<br>Change form baseline in mean nasal blockage score(NBS);Timepoint(s) of evaluation of this end point: week 56
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change from baseline in difficulty with sense of smell (DSS) score<br>• Change from baseline in Lund Mackay score<br>• Change from baseline in SinoNasal Outcome Test (SNOT-22) score.<br>• Time to first nasal polyp surgery<br>• Time to first SCS course for NP<br>• Change from baseline in nasal symptom score(s);Timepoint(s) of evaluation of this end point: week 56