Recruiting

Dupilumab

Sponsor:

Montefiore Medical Center

Code:

NCT05246267

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Study Details

Brief summary:

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study ID

NCT05246267

Start date

Feb 15, 2022

Status verified date

Jan, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group

Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.

Interventions

Dupilumab

Standard of care treatment with dupilumab

Primary outcome measure

  • 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 ]
  • 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 ]
  • Change in nasal peak flow (NPF) value (L/min) [ Time Frame: at 2, 16, 36, and 52 weeks of treatment ]

Central Contacts and Locations

Central contacts

Golda Hudes, MD

866-633-8255ghudes@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Golda Hudes, MD

866-633-8255ghudes@montefiore.org

Principal Investigator:

Golda Hudes, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • CRSwNP
  • dupilumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-01-22.