NCT06824649 Biologics in Chronic Rhinosinusitis With Nasal Polyposis
| NCT ID | NCT06824649 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of South Carolina |
| Condition | Chronic Sinusitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 504 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 504 participants in total. It began in 2026-06-03 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Zachary Soler, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06824649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Sinusitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06824649 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06824649 currently recruiting?
Yes, NCT06824649 is actively recruiting participants. Contact the research team at ENTResearch@ohsu.edu for enrollment information.
Where is the NCT06824649 trial being conducted?
This trial is being conducted at Phoenix, United States, Gainesville, United States, Portland, United States, Charleston, United States and 1 additional location.
Who is sponsoring the NCT06824649 clinical trial?
NCT06824649 is sponsored by Medical University of South Carolina. The principal investigator is Zachary Soler, MD at Medical University of South Carolina. The trial plans to enroll 504 participants.