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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246267
• Other study ID #: 2021-13161
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: Golda Hudes, MD
• Phone: 866-633-8255
• Email: ghudes[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Rhinosinusitis
• Sinusitis

Intervention

Biological:
• Dupilumab
Standard of care treatment with dupilumab

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L	Measure changes in uLTE4 levels from baseline	at 2, 16, 36, and 52 weeks of treatment
Secondary	Change in peripheral blood eosinophil counts in k/uL	Measure changes in peripheral blood eosinophil counts from baseline	at 2, 16, 36, and 52 weeks of treatment
Secondary	Change in Immunoglobulin E (IgE) level in IU/mL	Measure changes in IgE levels from baseline	at 2, 16, 36, and 52 weeks of treatment