Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dupilumab Prefilled Syringe

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Virginia

Lead sponsor

Regeneron Pharmaceuticals

Collaborator