Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04362501
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Sinusitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — BIOLOGICAL
    300mg dupixent SC every two weeks for six months
  • placebo — DRUG
    placebo SC injection every two weeks for six months

Study Details

The overarching objective of this study is to determine the clinical effectiveness of dupilumab for the treatment of CRS that includes several potential disease endotypes with the exclusion of the nasal polyp cluster that has previously been determined. The additional information gained from secondary and exploratory outcomes will help provide important insight for applied research studies and may also provide practical guidance to clinicians on how to select patients for treatment.

Key Dates

Start date
Oct 15, 2020
Status verified
Oct 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dupilumab treatment group
    dupilumab treatment group
  • Placebo Comparator: placebo group
    placebo group

Primary Outcome Measure

SNOT-22 [ Time Frame: Every two weeks for six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21224-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University School of Medicine· Baltimore, MD

Related Studies