Patients with chronic rhinosinusinusitis with nasal polyps MedDRA version: 20.0 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Benralizumab
Product Code: [NA]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Benralizumab
Current Sponsor code: ND
Concentration unit: mg milligram(s)
Concentration t
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion 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 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Patients < 18 years age - Pregnant women. If not pregnant, the patient must agree to voluntarily adopts highly effective contraceptive measures (intrauterine device [IUD] in copper; diaphragm; condom [from the partner], spermicide, hormonal contraceptive [i.e. birth control pill] and abstinence [no heterosexual activity]) to prevent pregnancy during the entire study period. - 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: a) Ongoing rhinitis medicamentosa b) Nasal septal deviation occluding at least one nostril c) Acute sinusitis, nasal infection, upper respiratory infections d) Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis e) Eosinophilic Granulomatosis with Polyangiitis (previously named Churg-Strauss Syndrome) f) Granulomatosis with Polyangiitis (previously named Wegener’s granulomatosis) g) Young’s Syndrome h) Kartagener’s Syndrome i) all ciliary dyskinesia j) Cystic Fibrosis - Patients with severe asthma, defined according to ERS/ATS definition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment, and to correlate the presence of baseline biomarkers with nasal polyp (NP) score improvement, in order to identify any possible predictive biomarker of response to Benralizumab.;Secondary Objective: In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of NP and consequently when Benralizumab treatment has to be reinstalled.;Primary end point(s): To assess the clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment. Outcome measures will be also put in correlation with baseline biomarkers assessed on biological samples (blood, serum, nasal polyp tissue, exhaled breath) in order to identify any possible predictive biomarker of response to Benralizumab. (see "Clinical evaluation, laboratory tests and follow-up" for more details).;Timepoint(s) of evaluation of this end point: In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of nasal polyps and consequently when Benralizumab treatment has to be reinstalled. | — |
Countries
Italy
Outcome results
None listed