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
Griffith University
25 participants
Aug 21, 2024
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
Plain Language Summary
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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 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.
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ACTRN12624000716561