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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Biologic Agents

    Biological/Vaccine

    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.

Treatment groups

504 Participants
are divided into 3 treatment groups
Group A: DupilumabActive comparator 1 intervention
Group B: OmalizumabActive comparator 1 intervention
Group C: MepolizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-Specific Quality of Life

The 22-item SinoNasal Outcome Test (SNOT-22; ©2006, Washington University, St. Louis, MO) will serve as the primary outcome of interest for all study aims/objectives. The SNOT-22 survey is a CRS-specific QOL instrument containing 22 questions (total summarized score range: 0-110) with high internal consistency and high test-retest reliability. The SNOT-22 utilizes Likert scales numbering from 0 ("No problem") to 5 "Problem as bad as it can be"). The SNOT-22 has been shown to discriminate between subjects with CRS and healthy controls, as well as identify significant differences after both medical and surgical treatments.

Time frame
24 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator