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Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

NCT04430179 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

Interventions

DRUG

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

300 mg every other week for 24 weeks

OTHER

Placebo

No active drug

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Seong Cho, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430179 on ClinicalTrials.gov