Recruiting

Biologics for CRSwNP

Sponsor:

Medical University of South Carolina

Code:

NCT06824649

Conditions

Chronic Sinusitis

Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biologic Agents

Study Details

Brief 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.

Conditions

Chronic Sinusitis

Nasal Polyps

Study ID

NCT06824649

Start date

Jun 3, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Baseline SNOT-22 total score > 30
  • Patient elects biologic therapy for the management of CRSwNP
  • Capable of receiving all 3 biologic therapy medications.
  • Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.

Exclusion Criteria:

  • 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)
  • Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
  • Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
  • Any previous treatment with any of the 3 biologic medications.
  • Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
  • Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.

Study Design

Enrollment

504 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dupilumab

active comparator: Omalizumab

active comparator: Mepolizumab

Interventions

Biologic 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.

Primary outcome measure

  • Disease-Specific Quality of Life [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Research Associate

(503) 494-5886ENTResearch@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Research Associate

(503)494-5886ENTResearch@ohsu.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Study Coordinator

843-792-9496sinus-research@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Sinusitis
  • Biologics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-03.