NCT05246267 · Montefiore Medical Center
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
What this study is about
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a group of participants of mostly ethnical and racial minority patients with CRSwNP
View original scientific description
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP
Interventions
BIOLOGICAL
Dupilumab
Standard of care treatment with dupilumab
Primary outcome measures
Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in SNOT-22 values from baseline
Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in UPSIT scores from baseline
Change in nasal peak flow (NPF) value (L/min)
Time frame: at 2, 16, 36, and 52 weeks of treatment
Measure changes in the NPF values from baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
- Patients aged 18 years and older.
- Patient willing to provide consent to be a participant in the study.
- Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"
Exclusion criteria
- Age under 18
- Suspected or diagnosed allergic fungal rhinosinusitis.
- Suspected or diagnosed cystic fibrosis.
- Dupilumab coverage denied through insurance or "Dupixent MyWay Program"
- Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible.
- Patients who were on a different biologic medication in the preceding 3 months.
- Patients with a diagnosis of EGPA/Churg-Strauss Syndrome
- Pregnant patients
- Patients with inverted papilloma growth
Where
- The Bronx, New York
Collaborators
Regeneron Pharmaceuticals, Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations