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Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 24, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Jul 2023 to Jul 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2023 to Jul 2025
    • Site details revised
    v6
  2. Notable Primary completion date: Jun 2022 to Jul 2023
    • Study completion date: Dec 2022 to Dec 2023
    v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Dec 17, 2020
    • Site details revised
    • Eligibility criteria expanded, about 3 words
    v4
  4. Notable Start date: Jun 2020 to Aug 2020v3
  5. Minor Secondary endpoints: details revised at 1 of 7 entriesv2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline.
Trial Details
NCT Number NCT04430179
Lead Sponsor University of South Florida
Conditions
(from sponsor)
Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov