Actively Recruiting

Early Phase 1
Age: 18Years - 100Years
All Genders
ID05895929

The Role of IL5 in Epithelial Cell Integrity

Led by Johns Hopkins University · Updated on 2026-01-12

8

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

G

GlaxoSmithKline

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying chronic rhinosinusitis with nasal polyps to understand how the drug mepolizumab affects the health and function of nasal airway cells. This early-phase laboratory study focuses on how mepolizumab may reduce inflammation and help maintain the barrier integrity of epithelial cells lining the nasal passages. The goal is to see how anti-IL5 treatment might improve cell function by reducing inflammation and epithelial dysfunction in nasal tissues. The study involves exposing human nasal epithelial cells, collected from patients with chronic rhinosinusitis with nasal polyps, to mepolizumab in a laboratory setting. These cells will be compared to cells exposed only to culture media without the drug. Researchers will examine the impact of mepolizumab on various inflammatory markers and epithelial barrier proteins over a period of up to 48 hours using advanced RNA sequencing and protein analysis techniques. This approach helps identify how anti-IL5 therapy influences immune responses and cell integrity. Participants provide nasal epithelial cells for laboratory testing. Researchers will measure changes in Type 1, Type 2, and innate immune inflammatory markers, as well as proteins related to epithelial barrier function and cell integrity during the 48-hour study period. The study is non-randomized with no masking, and results will help identify potential biomarkers related to anti-IL5 treatment effects. The trial is sponsored by Johns Hopkins University and includes adults aged 18 to 100 years with confirmed chronic rhinosinusitis with nasal polyps.

CONDITIONS

Brief Title

The Role of IL5 in Epithelial Cell Integrity

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Sinonasal inflammation lasting more than 12 weeks with at least two symptoms such as nasal obstruction, nasal discharge, facial pressure or pain, or reduced sense of smell
  • Confirmation of symptoms by CT scan evidence of sinus inflammation or endoscopic exam showing purulence
  • Presence of nasal polyps confirmed by endoscopic exam or sinus CT scan
Not Eligible

You will not qualify if you...

  • Children under 18 years old
  • Pregnant or lactating females
  • Prisoners
  • Mentally disabled individuals
  • Persons unable to give informed consent
  • Disease caused by clear anatomical issues like facial trauma or sinonasal tumors
  • Use of oral or intravenous glucocorticoids within 2 weeks before surgery
  • Use of immunomodulatory biologic drugs such as omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Trial Site Locations

Total: 2 locations

1

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21117

Actively Recruiting

2

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

J

Jean Kim, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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