Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Key facts
- Who runs it
- Medical University of South Carolina
- Where
- Charleston, Gainesville, Nashville, Phoenix, and Portland, United StatesSee the 5 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 504 people, planned
- Started
- 3 Jun 2026
- Expected to end
- Feb 2030
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Biologic Agents
- Record updated
- 10 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization
- Oral corticosteroid use within 30-days preceding enrollment / randomization
- Any previous treatment with any of the 3 biologic medications
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care
- Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
- 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)
- 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
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization
- Comorbid cystic fibrosis, CVID, or ciliary dyskinesia
Where in United States
- Medical University of South CarolinaCharleston, United StatesContact: Study CoordinatorTaking people
- UF Health ENT and Allergy - The OaksGainesville, United StatesContact: Study CoordinatorTaking people
- Vanderbilt University Medical CenterNashville, United StatesContact: Taylor Hill Study CoordinatorTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesContact: Faviola Trujillo Associate Clinical Research CoordinatorTaking people
- Oregon Health and Science UniversityPortland, United StatesContact: Research AssociateTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- DupilumabExisting treatment, for comparison
Treatment: Biologic Agents
- OmalizumabExisting treatment, for comparison
Treatment: Biologic Agents
- MepolizumabExisting treatment, for comparison
Treatment: Biologic Agents
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
- Record updated
- 10 November 2026