Actively Recruiting
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Led by University of Virginia · Updated on 2025-04-01
20
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity. Primary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment. Secondary Objectives will be to correlate reduction in Staph aureus abundance and improved bacterial diversity with increased expression of anti-microbial proteins (ß-defensins1-4) and cathelicidin LL-37. In addition, the investigators will correlate improvements in microbial diversity/decreased staph abundance with clinical improvements as assessed via questionnaires and objective/subjective smell function and also as improvements in cellular/immune T2 inflammation as assessed by reduced expression of T2 cytokines/chemokines and eosinophil/eosinophil-derived proteins.
CONDITIONS
Official Title
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- History of chronic rhinosinusitis with nasal polyposis (CRSwNP), including aspirin-exacerbated respiratory disease (AERD)
- Sinonasal culture positive for Staphylococcus aureus at first visit
- History of functional endoscopic sinus surgery (FESS) with patent sinus ostia allowing sample collection
- Well-controlled asthma, if present
- Well-controlled atopic dermatitis, if present
- Use of nasal saline irrigation and stable dosing of topical corticosteroids for more than 1 month allowed
- Physician plans to start dupilumab as part of standard care
- Meets FDA-approved criteria for dupilumab use for nasal polyps
You will not qualify if you...
- Serious concurrent medical problems
- Uncontrolled asthma (Asthma Control Test score less than 20 at screening)
- Use of oral corticosteroids within 60 days
- Urgent care, emergency department visit, or hospitalization for asthma within 60 days
- Current smoker or history of smoking more than 10 pack-years
- Use of biologic therapy, including for asthma, within last 3 months
- Change in chronic rhinosinusitis treatment within 1 month prior to study
- Upper respiratory infection within 6 weeks
- Antibiotic use within 6 weeks
- Pregnant or breastfeeding women
- Any contraindication to dupilumab including previous hypersensitivity reactions
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
K
Kristin W Wavell Shifflett, BS
CONTACT
D
Deborah Murphy, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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