Early-onset Dupilumab Effects in CRSwNP

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06188871
Phase
PHASE4
Status
Withdrawn

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Two injections of 300mg dupilumab, subcutaneous 14 days apart

Study Details

While it is known that Dupilumab has profound effects in patients with CRSwNP, these are often seen months later after treatment initiation; however, in practice, patients often endorse feeling significantly better within days of their first injection. No studies have investigated the molecular basis for such an acute change. This study proposes that specific cytokine changes in phenotype in addition to microbiome and oscillometry effects play a synergistic role in producing this effect.

Key Dates

Start date
Jun 1, 2024
Status verified
May 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dupilumab
    Two injections of 300mg dupilumab, subcutaneous 14 days apart

Primary Outcome Measure

Mean change in concentration of IgE (IU/mL) [ Time Frame: 3 weeks post baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Department of Otolaryngology Head and Neck SurgeryRochesterNew York14642-

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By research site
University of Rochester Department of Otolaryngology Head and Neck Surgery· Rochester, NY

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