Topics

NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab

2019-12-09 00:56:01 | BioPortfolio

Summary

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.

Objectives:

- 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.

Study Design

Conditions

Nasal Polyps

Intervention

Benralizumab, Placebo

Location

Humanitas Clinical and Research Hospital
Rozzano
MI
Italy
20089

Status

Recruiting

Source

Humanitas Clinical and Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-09T00:56:01-0500

Clinical Trials [1125 Associated Clinical Trials listed on BioPortfolio]

Effect of Benralizumab in Patients With Severe Nasal Polyps

This is a randomized placebo controlled trial to evaluate the effect of benralizumab on people with severe nasal polyps.

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg...

Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks...

Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis

Benralizumab will be used in a placebo controlled randomized study to treat severe chronic rhinosinusitis with nasal polyps

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had ...

PubMed Articles [1440 Associated PubMed Articles listed on BioPortfolio]

Staphylococcus aureus internalisation in mast cells in nasal polyps - Characterisation of interactions and potential mechanisms.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common chronic condition. The exact cause of nasal polyps remains unknown. Recently, we made the novel observation of intracellular localisation ...

Nasal Polyps and Future Risk of Head and Neck Cancer: A Nationwide Population-based Cohort Study.

Nasal polyps is a common condition with a significant impact on quality of life. The association between nasal polyps and future risk of head and neck cancer is unknown.

Comparison of Corticosteroids by 3 Approaches to the Treatment of Chronic Rhinosinusitis With Nasal Polyps.

Corticosteroids are regarded as the mainstay of medical treatment of eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP). To date, a head-to-head comparison of the efficacy and safety of g...

Increased thrombin activatable fibrinolysis inhibitor (TAFI) in chronic rhinosinusitis with nasal polyps.

Chronic rhinosinusitis (CRS) is a heterogeneous chronic inflammatory disease subdivided based on presence or absence of nasal polyps (NPs). Histological features of CRS with NPs (CRSwNP) include infla...

Cross-talk between Th2 and Th17 pathways in chronic rhinosinusitis with nasal polyps.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease with a spectrum of endotypes. Th2 and Th17 related cytokines are two central regulators involved in the inflammation associ...

Medical and Biotech [MESH] Definitions

Focal accumulations of EDEMA fluid in the NASAL MUCOSA accompanied by HYPERPLASIA of the associated submucosal connective tissue. Polyps may be NEOPLASMS, foci of INFLAMMATION, degenerative lesions, or malformations.

Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.

The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.

Application of allergens to the nasal mucosa. Interpretation includes observation of nasal symptoms, rhinoscopy, and rhinomanometry. Nasal provocation tests are used in the diagnosis of nasal hypersensitivity, including RHINITIS, ALLERGIC, SEASONAL.

Discrete tissue masses that protrude into the lumen of the COLON. These POLYPS are connected to the wall of the colon either by a stalk, pedunculus, or by a broad base.

More From BioPortfolio on "NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Biotechnology Business
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...


Searches Linking to this Trial