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

NCT ID: NCT05246267

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2026-06-30

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

Detailed Description

First, it will confirm the effectiveness of dupilumab in the treatment of CRSwNP in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biologics in CRSwNP Second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in CRSwNP patients and its association with symptom improvement.

Finally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with CRSwNP and comorbid asthma.

There will be a screening visit, followed by a baseline visit where the medication will be given. Follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. Long-term visits will take place in 36 and 52 weeks.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

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

Dupilumab

Intervention Type: BIOLOGICAL

Standard of care treatment with dupilumab

Interventions

Dupilumab

Standard of care treatment with dupilumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Golda Hudes, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Golda Hudes, MD

Role: CONTACT

ghudes@montefiore.org

866-633-8255

Facility Contacts

Golda Hudes, MD

Role: primary

ghudes@montefiore.org

866-633-8255

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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

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://grants.nih.gov/grants/guide/notice-files/not-od-15-089.html

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

Other Identifiers

2021-13161

Identifier Type: -

Identifier Source: org_study_id