RecruitingPhase 2ACTRN12624000716561

The effect of biologics on patients with nasal polyp eosinophilia.

Spatial mapping of Dupilumab-induced molecular changes in nasal polyp eosinophilia and type 2 inflammation: towards optimised treatment


Sponsor

Griffith University

Enrollment

25 participants

Start Date

Aug 21, 2024

Study Type

Interventional

Conditions

Summary

This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with NP treated with Dupilumab for a 26 week plus a post-treatment visit at three months. At baseline and every 2 weeks patients will have a clinical assessment and complete a series of questionnaires. A blood sample and a nasal mucosal biopsy will be collected every 4 weeks. Protein and RNA analysis will be performed using the GeoMx™ DSP /CosMx™ single cell SMI platforms on tissue samples at baseline, week 4, week 12 and week 26. The objective of this study is to identify and assess the tissue histopathological changes in response to mepolizumab and/or dupilumab therapy in patients with nasal polyp eosinophilia.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition where the lining of the nasal passages and sinuses becomes persistently inflamed, forming soft growths called polyps that block breathing, affect smell, and cause facial pain. In some patients, this is driven by a type of white blood cell called eosinophils. Dupilumab is a biologic medication that blocks a key inflammatory pathway linked to eosinophil-driven disease. This Phase 2 study from Griffith University will treat 25 adults with uncontrolled eosinophilic nasal polyp disease with dupilumab for 26 weeks. Using cutting-edge tissue analysis platforms, researchers will track exactly how the tissue in the nasal lining changes at a molecular and cellular level at multiple time points — providing detailed insight into how dupilumab works in this condition. You may be eligible if you are an adult (18+) with nasal polyp eosinophilia that is not adequately controlled by standard treatments, and you are not currently on dupilumab, mepolizumab, or benralizumab. People with known hypersensitivity to dupilumab, immune deficiency, cystic fibrosis, or conditions that elevate eosinophils for other reasons (such as Churg-Strauss syndrome) are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with Nasal Polyps (NP) treated with Dupilumab for a

This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with Nasal Polyps (NP) treated with Dupilumab for a 26 week plus a post-treatment visit at three months. The Dupilumab treatment will consist of the following: Dupilumab • Trade name: Dupixent • Dosage regimen: for chronic rhinosinusitis 300mg subcutaneous injection once every 2 weeks for 24 weeks. • Participants will also undergo a blood test, endoscopy and FENO (fractional exhaled nitric oxide) test at each second visit (once per month). Adverse and serious adverse event recording will occur at each visit.


Locations(1)

Sydney ENT Clinic - Darlinghurst

NSW, Australia

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ACTRN12624000716561