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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 1, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 30, 2024 to Jun 30, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v7
  2. Phase: Not applicable to Phase 4v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2022 to Sep 1, 2022
    v5
  4. Primary completion date: Dec 31, 2023 to Jun 30, 2024
    • Start date: May 30, 2022 to Jul 1, 2022
    v4
  5. Start date: Feb 1, 2022 to May 30, 2022v3
  6. Start date: Nov 1, 2021 to Feb 1, 2022
    • Primary completion date: Oct 31, 2023 to Dec 31, 2023
    • Study completion date: Oct 31, 2024 to Dec 31, 2024
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05094570
Lead Sponsor University of Virginia
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Nasal Polyps, Staphylococcus Aureus
Related terms Nasal Polyps, Staphylococcal Infections
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov