Mechanisms of Smell Improvement With Dupilumab.

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05964465
Phase
PHASE4
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Monoclonal antibody blocking interleukin 4 and interleukin 13

Study Details

This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.

Key Dates

Start date
Aug 10, 2023
Status verified
Feb 2026
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.

Primary Outcome Measure

Change in volumetric olfactory cleft opacification based on CT. [ Time Frame: 3 months post-treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of VirginiaCharlottesvilleVirginia22904-

Find similar trials in Charleston, SC

By research site
Medical University of South Carolina· Charleston, SCUniversity of Virginia· Charlottesville, VA

Related Studies