Biologics in Chronic Rhinosinusitis With Nasal Polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study investigates biologic therapies for adults with chronic rhinosinusitis with nasal polyps who elect to receive biologic treatment. Participants must have bilateral nasal polyps, a nasal polyp score above 5, and a SNOT-22 score above 30, and they must be able to receive all three biologic medications studied. The trial aims to identify which biologic, or combination of factors, best predicts response to treatment and to improve understanding of biomarkers that may guide therapy. Conducted at multiple sites, the study builds on prior approvals of dupilumab, omalizumab, and mepolizumab by exploring real-world effectiveness and patient-specific outcomes. Endpoints likely include symptom relief, polyp burden, and quality of life over the treatment course.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• UF Health ENT and Allergy - The Oaks
  Gainesville, Florida, United States Recruiting
• Oregon Health and Science University
  Portland, Oregon, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Zachary Soler, MD — Medical University of South Carolina
• Study coordinator: Research Associate
• Email: ENTResearch@ohsu.edu
• Phone: (503) 494-5886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

  This study tests whether metabolic and immune markers in nasal tissue and blood differ between people with nasal polyps and those without, to help understand CRSwNP and find potential diagnostic clues.

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• GSK5784283 as add-on therapy for chronic rhinosinusitis with nasal polyps

  This study tests whether GSK5784283 added to standard care can help adults with chronic rhinosinusitis with nasal polyps feel better and have fewer symptoms.

  Recruiting at 8 sites Phase 3 GlaxoSmithKline · Los Angeles, California and 7 other locations · NCT07782970

• GSK5784283 as add-on maintenance therapy for nasal polyps in chronic rhinosinusitis

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• Triamcinolone-loaded nanocapsules after endoscopic nasal surgery

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  Recruiting Phase 2 Deraya University · Minya, Menia Governorate · NCT07714525

• Depemokimab monotherapy for chronic rhinosinusitis with nasal polyps in Japanese adults

  This study tests depemokimab alone (without intranasal corticosteroids) in adults with chronic rhinosinusitis with nasal polyps in Japan.

  Recruiting at 10 sites Phase 4 GlaxoSmithKline · Ehime and 9 other locations · NCT07701967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.