Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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 criteria

Qualifiers

Age > 18 years

Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria

Bilateral nasal polyposis visible on sinonasal endoscopy

Nasal polyp score > 5

Disqualifiers

Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Endoscopic sinus surgery within 6-months preceding enrollment / randomization.

Oral corticosteroid use within 30-days preceding enrollment / randomization.

Serum IgE level outside the dosing range for omalizumab (i.e., <30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)

Trial design

Treatments tested in this trial

  • Biologic Agents

Treatment groups

504 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator