Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Last updated: August 12, 2024
Sponsor: Johns Hopkins University
Overall Status: Completed

Phase

1

Condition

Polyps

Sinusitis

Sinus Infections

Treatment

Omalizumab

Clinical Study ID

NCT04583501
IRB00255799
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sinonasal inflammation for greater than 12 weeks which include at least 2 of thefollowing symptoms: nasal obstruction/congestion, nasal discharge (anterior orposterior), facial pressure/pain, reduction of sense of smell

  • Confirmation of the clinical symptoms by (2a) CT scan evidence of paranasal sinusmucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from thesinuses or ostiomeatal complex

  • Presence of nasal polyps seen on endoscopic exam or sinus CT scan

  • Adults from age of 18-100 will be eligible

  • All potential participants will be required to sign an Institutional Review Board (IRB) approved research consent form.

Exclusion

Exclusion Criteria:

  • Children under the age of 18 will be excluded

  • No pregnant or lactating females, prisoners, mentally disabled, or persons unable togive informed consent will be contemplated for inclusion.

  • The subject groups will also exclude those with disease secondary to a clearlydefined anatomic process, such as facial trauma, and obstruction due to sinonasalneoplasm.

  • To eliminate confounding variables in our ex vivo experimental studies, any subjectwith a history of exposure to oral or systemic IV glucocorticoids within 2 weeks ofsurgery or any immunomodulatory biologics will be excluded. These include, but arenot limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab,benralizumab, reslizumab, or rituximab.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Omalizumab
Phase: 1
Study Start date:
December 15, 2020
Estimated Completion Date:
July 12, 2024

Study 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.

Connect with a study center

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21117
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

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