Biologics in Chronic Rhinosinusitis With Nasal Polyposis

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.

Recruiting

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Key information

Conditions

Chronic Sinusitis Infections Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health and Science University, Portland, Oregon, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biologic Agents

Biological

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 outcomes

Disease-Specific Quality of Life

Time frame: 24 weeks

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Associate

CONTACT

[email protected]

(503) 494-5886

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Acronym: CRSwNP

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Feb 13, 2025
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed