NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab (NAPPREB)
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|ClinicalTrials.gov Identifier: NCT04185012|
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : November 18, 2021
Background and rationale:
Phase III-b study.
Population and patient selection 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 Sample size: 20 subjects.
Study design and study duration:
This is a pilot, prospective, double-blind placebo-controlled (DBPC) phase III-b trial with Benralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks (followed up at 32 and 52 weeks) in patients with chronic rhinosinusinusitis with nasal polyps (CRSwNP).
Description of study treatment/product/intervention: Benralizumab, 30 mg subcutaneously every 4 week for the first 3 doses, and then every 8 weeks.
- Primary 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 nasal polyps and consequently when Benralizumab treatment has to be reinstalled.
- Safety objective: To evaluate the safety and tolerability of Benralizumab in patients with CRSwNP
Statistical methods, data analysis: Descriptive analysis of all collected variables at all time-points will be performed. Patients will be classified into "responders" and "non responders", for primary endopoint variable. Continuous variables will be evaluated with the normality test of Kolmogorov-Smirnov and compared with ANOVA or the Mann-Whitney test, depending on the normality of distribution. Categorical variables will be compared using Fisher's exact test.
Ethical considerations: The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the Sponsor policy on Bioethics and Human Biological Samples.
|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyps||Biological: Benralizumab Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled clinical trial. Patients will be divided in two arms with 1:1 randomization to Treatment or Placebo.|
Randomization will occur by assigning a unique sequential study code to a balanced number of randomly assorted treatment vials.
An online open source randomization software will be used to assign treatment groups, and this will be done by an external person from those who will follow and treat the patients.
Patients randomization will be blinded to the patients themselves and to all the personnel that will have contact with them during the trial
|Official Title:||NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||March 28, 2022|
|Estimated Study Completion Date :||July 30, 2022|
Benralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks
Benralizumab 30 mg administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
Placebo Comparator: Placebo
Placebo administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks
Placebo administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
- Significant reduction of the Nasal polyps Score (range: 0-8; higher values mean larger nasal polyps size) [ Time Frame: at week 24 (vs baseline) ]score reduction of 1.5
- Reduction in Lund-MacKay Score (range: 0-24; higher values mean larger nasal polyps extension) [ Time Frame: at week 24 (vs baseline) ]>50% of baseline
- Improvement of Sino-Nasal Outcome Test (SNOT-22; range: 0-110; higher values mean poorer disease-related quality of life) [ Time Frame: at week 24 (vs baseline) ]>40% of baseline
- Improvement of smell Visual Analogue Scale (VAS; range: 0-10; higher values mean worse smell) [ Time Frame: at week 24 (vs baseline) ]>50% of baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185012
|Contact: Giorgio Walter Canonica, MDfirstname.lastname@example.org|
|Contact: Enrico Heffler, MD, PhDemail@example.com|