Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06824649 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Study acronym: CRSwNP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 2 to 3 Eligibility criteria expanded, about 18 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 18 words
  2. Site contacts updated at 1 of 2 sitesv8
  3. Study sites: 1 to 2v7
  4. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jun 30, 2026 to Jun 3, 2026v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2026 to Jun 3, 2026
  5. Start date: Apr 30, 2026 to Jun 30, 2026v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Mar 2026 to Apr 30, 2026v4
  2. Start date: Sep 2025 to Mar 2026 Collaborators expanded, about 5 wordsv3 Show 1 more changeShow less
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Mar 2025 to Sep 2025 Collaborators shortened, about 5 wordsv2 Show 1 more changeShow less
    • Collaborators shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
Trial Details
NCT Number NCT06824649
Lead Sponsor Medical University of South Carolina
Collaborators: National Institutes of Health (NIH)
Conditions Chronic Sinusitis, Nasal Polyps
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov