NCT04430179

Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

An Evaluation of Dupilumab in Patients With Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline.

Detailed description

The investigators will use high blood eosinophils (\>=200) as a biomarker for eosinophilic CRSsNP and investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline. In addition, the investigators will have a prespecified enrollment goal of at least 50% of patients with type 2 inflammatory diseases such as asthma, allergic rhinitis, and/or atopic dermatitis on the basis of patient-reported history and will stratify subject numbers between dupilumab treatment and placebo group.

Conditions

• Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

Interventions

Type	Name	Description
DRUG	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	300 mg every other week for 24 weeks
OTHER	Placebo	No active drug

Timeline

• Start date: 2020-12-17
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2020-06-12
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study