NCT05094570 · University of Virginia
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
What this study 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.
View original scientific description
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.
Interventions
DRUG
Dupilumab Prefilled Syringe
Dupilumab 300 mg
Primary outcome measures
To demonstrate that dupilumab reduces staphylococcus aureus
Time frame: 16 weeks
To demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance. The abundance of Staph aureus will be determined using qPCR of the femA gene and compared at baseline and after 16 weeks of dupilumab treatment. Statistical differences in the quantity of staph aureus (as ascertained by qPCR) will be determined utilizing data obtained from all subjects comparing data obtained at the end of the study in comparison to the beginning of the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Charlottesville, Virginia
Collaborators
Regeneron Pharmaceuticals
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2025 · Source of record for eligibility and locations