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NCT06824649

Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Recruiting
PHASE4Ages 18+InterventionalTreatment
Medical University of South Carolina
~504 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Biologic Agents

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Specific Quality of Life
Measured over 24 weeks

Conditions

Chronic Sinusitis
Nasal Polyps

Explore related trials

Chronic rhinosinusitis with multiple nasal polyps

Where it's being run

2 sites across 2 states
Oregon1
South Carolina1

Study leadership

  • Zachary Soler, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Research Associate
[email protected]
(503) 494-5886
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease-Specific Quality of Life24 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.