RecruitingPhase 4NCT06824649

Biologics in Chronic Rhinosinusitis With Nasal Polyposis

SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis


Sponsor

Medical University of South Carolina

Enrollment

504 participants

Start Date

Jun 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Biologic Agents for people with chronic sinusitis and nasal polyps. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBiologic Agents

Evidence by way of phase III clinical trials has shown efficacy of dupilumab, omalizumab, and mepolizumab to placebo, leading to regulatory approval and widespread clinical use. However, data from these clinical trials does not show universal improvement and ideal control of disease across all patients with Chronic Sinusitis with Nasal Polyps (CRSwNP). Successful completion of this trial will help answer some of the most pressing clinical questions related to biologics and CRSwNP. Specifically, findings 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.


Locations(2)

Oregon Health and Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06824649


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