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NCT Number: NCT05246267

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Golda Hudes, MD

CONTACT

[email protected]

866-633-8255

Golda Hudes, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dupilumab

Biological

Standard of care treatment with dupilumab

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

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

    Time frame: at 2, 16, 36, and 52 weeks of treatment

    Measure changes in uLTE4 levels from baseline

  2. Change in peripheral blood eosinophil counts in k/uL

    Time frame: at 2, 16, 36, and 52 weeks of treatment

    Measure changes in peripheral blood eosinophil counts from baseline

  3. Change in Immunoglobulin E (IgE) level in IU/mL

    Time frame: at 2, 16, 36, and 52 weeks of treatment

    Measure changes in IgE levels from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Golda Hudes, MD

CONTACT

[email protected]

866-633-8255

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Mayo Clinic
  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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