Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective different biologic medications are for treating chronic rhinosinusitis with nasal polyps (CRSwNP), a condition that affects many people and causes symptoms like nasal congestion and sinus pressure. Recently, biologic treatments have been developed, but it's unclear which one works best for different patients. The goal of this trial is to find out if one biologic is better than the others and if certain tests can help predict which patients will respond well to these treatments.

To participate in the trial, you must be over 18 years old and have a confirmed diagnosis of CRSwNP with visible nasal polyps. You should also have a high nasal polyp score and a significant level of symptoms as measured by a specific questionnaire. Participants will need to have been using a nasal corticosteroid for at least a month before joining the study and must not have had recent surgery or certain other medical conditions. If you join the trial, you can expect to receive one of the biologic treatments and will be monitored closely to see how well it works for you. This study could provide valuable information to help doctors choose the best treatment for individuals with CRSwNP in the future.

Gender

ALL

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.