Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- University of South Florida
- Study ID
- NCT04430179
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] — DRUG300 mg every other week for 24 weeks
- Placebo — OTHERNo active drug
Study Details
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.
Key Dates
- Start date
- Dec 17, 2020
- Status verified
- Jan 2025
- Primary completion
- Jul 31, 2025
- Completion
- Jul 31, 2025
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active drugDupilumab 300 mg every other week for 24 weeks
- Placebo Comparator: PlaceboPlacebo
Primary Outcome Measure
Change in Lund-Mackay sinus computed tomography (LMK-CT) score [ Time Frame: 24 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Florida Asthma, Allergy and Immunology | Tampa | Florida | 33613 | - |