Actively Recruiting

Age: 18Years - 99Years
All Genders
ID05246267

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

Led by Montefiore Medical Center · Updated on 2026-01-22

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the addition of dupilumab, a biological treatment, to standard intranasal corticosteroids for patients with chronic rhinosinusitis with nasal polyps (CRSwNP), focusing on a mostly ethnical and racial minority population. This study aims to confirm dupilumab's effectiveness in these underrepresented groups, establish a biomarker indicating therapeutic response, and assess its impact on asthma symptoms and lung function in those with comorbid asthma. Participants will receive dupilumab according to FDA-approved use alongside their standard care. The study includes a screening visit, a baseline visit for treatment administration, and follow-ups at 2 weeks, 16 weeks, 36 weeks, and 52 weeks to monitor progress and effects. These visits will track changes in symptoms and biological markers over time. During the study, participants will complete evaluations such as the Sinonasal Outcome Test (SNOT-22), the University of Pennsylvania Smell Identification Test (UPSIT), and nasal peak flow measurements at multiple time points. Researchers will also monitor urinary leukotriene E4, blood eosinophil counts, and immunoglobulin E levels to understand the biological effects of dupilumab. The total participation lasts about one year with scheduled assessments to observe treatment impact and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with physician-diagnosed chronic rhinosinusitis with nasal polyps (CRSwNP), with or without asthma, meeting FDA-approved criteria for Dupilumab use
  • Patients aged 18 years and older
  • Patients willing to provide consent to participate in the study
  • Patients with insurance coverage for Dupilumab or coverage through the "Dupixent MyWay Program"
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Suspected or diagnosed allergic fungal rhinosinusitis
  • Suspected or diagnosed cystic fibrosis
  • Dupilumab coverage denied by insurance or the "Dupixent MyWay Program"
  • Use of steroid taper in the past 30 days, except for chronic steroid use up to 20 mg prednisone daily
  • Use of any biologic medication in the past 3 months
  • Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)/Churg-Strauss Syndrome
  • Pregnancy
  • Presence of inverted papilloma growth

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 52 weeks

Participants receive dupilumab treatment and undergo assessments to measure symptom improvement and biological response.

1 baseline visit, followed by visits at 2 weeks and 16 weeks

Long-term Monitoring

Duration - From Week 36 to Week 52

Participants are monitored for long-term effects of dupilumab treatment on symptoms and biomarkers.

Visits at 36 and 52 weeks

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

Loading map...

Research Team

G

Golda Hudes, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

3D Printing for Topical Nasal Corticosteroid Irrigations: a ...

Chronic Rhinosinusitis With Nasal Polyps

Actively Recruiting

1 location

A Multicentre, Single-Arm, Phase 3b Study to Assess Changes ...

Chronic Rhinosinusitis With Nasal Polyps

Actively Recruiting

45 locations

BIFANG: A Multicentre, Single-Arm, Phase 3b Study to Assess ...

Chronic Rhinosinusitis With Nasal Polyps

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.

Claus Bachert, Leda Mannent, Robert M Naclerio...

https://pubmed.ncbi.nlm.nih.gov/26836729

Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials.

Claus Bachert, Joseph K Han, Martin Desrosiers...

https://pubmed.ncbi.nlm.nih.gov/31543428

Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma.

Claus Bachert, Peter W Hellings, Joaquim Mullol...

https://pubmed.ncbi.nlm.nih.gov/30928658

Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis.

Jorge F Maspero, Constance H Katelaris, William W Busse...

https://pubmed.ncbi.nlm.nih.gov/31351189

African American Patients with Chronic Rhinosinusitis Have a Distinct Phenotype of Polyposis Associated with Increased Asthma Hospitalization.

Mahboobeh Mahdavinia, Mohamed Benhammuda, Christopher D Codispoti...

https://pubmed.ncbi.nlm.nih.gov/26868728