Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04185012
Eligibility Criteria:
Inclusion Criteria:
Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
* Nasal polyps score (Meltzer et al.) \> 5
* Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) \> 24
* Provision of informed consent prior to any study specific procedure
Exclusion Criteria:
* Patients \< 18 years age
* Pregnant women
* Biologic therapy in the past 6 months (or at least a period corresponding to 5 half-life of used drugs) (eg: omalizumab, mepolizumab, reslizumab, dupilumab)
* Previous treatment with Benralizumab
* Known hypersensitivity to benralizumab or any of its excipients
* Immunosuppression other than oral steroids in the past 3 months
* Allergen immunotherapy in the past 6 months
* Serious life threatening cardiopulmonary disorders
* Systemic immunologic disorder in the last 12 months
* Positive history for malignant tumors ever in patient's life
* Patients with conditions or concomitant diseases making them non evaluable at visit 1 or for the primary efficacy endpoint:
1. Ongoing rhinitis medicamentosa
2. Nasal septal deviation occluding at least one nostril
3. Acute sinusitis, nasal infection, upper respiratory infections
4. Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis
5. Eosinophilic Granulomatosis with Polyangiitis (previously named Churg-Strauss Syndrome)
6. Granulomatosis with Polyangiitis (previously named Wegener's granulomatosis)
7. Young's Syndrome
8. Kartagener's Syndrome
9. all ciliary dyskinesia
10. Cystic Fibrosis
* Systemic corticosteroid treatment for other chronic conditions (i.e.: autoimmune disorders, tumors,….)
* Evidence of active systemic immunedepression (i.e..: primary or secondary immunodeficiency)
* Patients with severe asthma, defined according to ERS/ATS definition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04185012
Study Brief:
Protocol Section:
NCT04185012