Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

NCT05246267 | Recruiting DMC FDA Drug

• 1 other identifier: 2021-13161
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

CRSwNP; dupilumab

Outcome Measures

Primary Outcomes (3)

• Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome

  Measure changes in SNOT-22 values from baseline

  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

  Measure changes in UPSIT scores from baseline

  at 2, 16, 36, and 52 weeks of treatment

• Change in nasal peak flow (NPF) value (L/min)

  Measure changes in the NPF values from baseline

  at 2, 16, 36, and 52 weeks of treatment

Secondary Outcomes (3)

• Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L

  at 2, 16, 36, and 52 weeks of treatment

• Change in peripheral blood eosinophil counts in k/uL

  at 2, 16, 36, and 52 weeks of treatment

• Change in Immunoglobulin E (IgE) level in IU/mL

  at 2, 16, 36, and 52 weeks of treatment

Study Arms (1)

Study group

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

Biological: Dupilumab

Interventions

Dupilumab BIOLOGICAL

Standard of care treatment with dupilumab

Study group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. These patients will be 18 years and older and will have insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Regeneron Pharmaceuticals: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (41)

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• Effect of 16-week Dupilumab Treatment on Sinonasal Respiratory Symptoms and Sense of Smell in Ethnically Diverse Patients with Chronic Rhinosinusitis with Nasal Polyposis

  RESULT

Related Links

• Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes. 2015.

Biospecimen

Retention: SAMPLES WITH DNA

Nasal inferior turbinate tissue, fluid, and microbiome collection

MeSH Terms

Interventions

dupilumab

Study Officials

• Golda Hudes, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Golda Hudes, MD

CONTACT

866-633-8255; ghudes@montefiore.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 18, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)