The Role of IL5 in Epithelial Cell Integrity

NCT05895929 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB00363909
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are:

1. 1.To see what mepolizumab does to suppress inflammation of the human cells.
2. 2.To see what mepolizumab does to maintain barrier integrity of epithelial cells

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (5)

• Change in Type 1 inflammatory markers (ng/mL)

  IL8 cytokine mRNA and protein expression

  0 to 48 hours

• Change in Type 2 inflammatory markers (ng/mL)

  IL5 and thymic stromal lymphopoietin cytokine mRNA and protein expression

  0 to 48 hours

• Change in Innate immune inflammatory markers (ng/mL)

  IL1 receptor mRNA and protein expression

  0 to 48 hours

• Change in epithelial barrier function protein expression (ng/mL)

  E-cadherin

  0 to 48 hours

• Change in epithelial integrity markers (staining intensity units)

  alpha-smooth muscle actin protein expression

  0 to 48 hours

Study Arms (2)

Mepolizumab treatment arm

EXPERIMENTAL

Nasal epithelial cells will be exposed in vitro to mepolizumab in culture.

Drug: Mepolizumab

Control arm

NO INTERVENTION

Nasal epithelial cells will be exposed in vitro to media without mepolizumab in culture

Interventions

Mepolizumab DRUG

In vitro exposure of human nasal epithelial cells to mepolizumab

Also known as: Nucala

Mepolizumab treatment arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell.
• (2) confirmation of the clinical symptoms by: (2a) CT scan evidence of paranasal sinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex; and
• (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.

You may not qualify if:

• \. Children under the age of 18 will be excluded due to:
• possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.
• lack of complete pneumatization of the majority of paranasal sinuses
• \. pregnant or lactating females,
• \. prisoners,
• \. mentally disabled
• \. disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.
• \. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery
• \. exposure to immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21117, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Kim, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Kim, MD PhD

CONTACT

410-550-2644; jeankim@jhmi.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nasal epithelial cells will be exposed to defined doses of mepolizumab in vitro culture (Arm 1) or control media without mepolizumab (Arm 2)

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 9, 2023
• Study Start: September 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (2)