NCT04583501

Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.

Detailed description

Objectives: Aim 1. The investigation will identify the specific tissue compartment distribution of immunoglobulin E (IgE) expression within human nasal polyps. Colocalization studies will examine functional interaction of IgE with effector cells. Aim 2. The investigation will examine the direct effect of omalizumab on expression of Type 2, 1, and 3 inflammatory pathways in human nasal polyp tissue from phenotypically characterized chronic rhinosinusitis with nasal polyposis (CRSwNP) patients. Study Rationale: Human nasal polyps express high local tissue IgE. However, the tissue distribution, cellular location and functional consequence of IgE accumulation within the polyp tissue is not known. Phase 3 studies of omalizumab demonstrated efficacy, with responders. However, the reason for non-responder outcomes in a subset of CRSwNP patients was not understood. Therefore, the goal of this study is to examine the mechanism of action of omalizumab in CRSwNP, such that specific responders for this treatment can be identified and therapy can be optimally directed.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab	Omalizumab will used as dose comparable to to 0.016 mg/kg/IU in serum.

Timeline

• Start date: 2020-12-15
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2020-10-12
• Last updated: 2024-08-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study