Recruiting

Dupilumab

Sponsor:

University of Virginia

Code:

NCT05094570

Conditions

Nasal Polyps

Staphylococcus Aureus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Dupilumab Prefilled Syringe

Study Details

Brief summary:

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

Nasal Polyps

Staphylococcus Aureus

Study ID

NCT05094570

Start date

Sep 1, 2022

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria: • Adults, ages 18-65

  • History of CRSwNP including subjects with AERD
  • Sinonasal culture demonstrating staph aureus at visit 1
  • History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus
  • Asthma, if present, should be well controlled
  • Atopic dermatitis, if present, should be well controlled
  • Use of nasal saline irrigation and stable dosing (>1 month) of topical corticosteroids is permitted
  • Intent of the physicians caring to start dupilumab therapy as part of subject's standard of care
  • Subject meets FDA approved criteria for the use of dupilumab for nasal polyps

Exclusion Criteria:

  • Concurrent serious medical problem
  • Uncontrolled asthma (ACT <20 at screening visit)
  • Recent (within 60 days) use of oral corticosteroids
  • Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
  • Current smoker or has smoked >10 pack-years
  • Biologic therapy including asthma biologic therapy in last 3 months
  • Recent (within 1 month) change in CRS medical treatment (topical steroids, surfactants, irrigation protocol, etc. including changes in delivery volume or delivery methodology)
  • Recent (within 6 weeks) upper respiratory infection
  • Antibiotics within 6 weeks
  • Pregnant or breast-feeding women
  • Any contraindication to the use of dupilumab including hypersensitivity on previous administration

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupilumab treatment

Treatment with dupilumab to demonstrate decreased staph prevalence and improve microbial diversity

Interventions

Dupilumab Prefilled Syringe

Dupilumab 300 mg

Primary outcome measure

  • To demonstrate that dupilumab reduces staphylococcus aureus [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Kristin W Wavell Shifflett, BS

4349246874kww7d@virginia.edu

Deborah Murphy, BSN

4349823510ddm9q@virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Deb Murphy, BSN

434-982-3510ddm9q@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Keywords

  • Nasal polyps
  • Staph aureus
  • Interleukin-4/-13

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-04-01.