IL-13 Blockade and Airway Autoimmunity in Asthma

Phase

N/A

Condition

Asthma

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT05564078

14816

Ages 18-100
All Genders

Study Summary

It has been observed that certain section of patients having severe to moderate Asthma, do not benefit from oral corticosteroids and IL-5 blocking biologics. There is increasing evidence that Airway auto immunity may be responsible for this poor response to treatment. It has been seen in earlier study done at Nair lab that these patients might benefit from Dupilumab, a biologic blocking IL-13/ IL-4. IL-13/IL-4 are the cytokines responsible for increased inflammation in these Asthmatics. The hypothesis is that blocking IL-13/IL-4 will also reduce the airway auto immunity which can be measured by comparing the auto immune markers in airway at baseline (before starting Dupilumab) and 16 weeks (after 4 months of Dupilumab treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Prior to the beginning of the study, patients must be willing and fully capable toprovide written informed consent
Subjects must be able and willing to comply with the study protocol
Asthma diagnosed by a respiratory physician ≥ 36 months prior to study enrollmentbased on the Global Initiative for Asthma (GINA) 2014 guidelines
Patients referred or routinely followed for asthma by Dr. Nair
Clinical indication to prescribe dupilumab or will enter a clinical trial wherepatient will receive drug for at least 4 months
ICS dose ≥ 500 mcg of fluticasone equivalent/day, and/or daily prednisone

Exclusion

Exclusion Criteria:

Current smoker defined as having smoked at least one cigarette (or pipe, cigar, ormarijuana) per day for ≥ 30 days within the three months prior to screening
Ex-smokers with ≥ 20 pack-year smoking history
Current pregnancy or lactation
Treatment with anti- Immunoglobulin E (IgE), anti-IL-5, or anti-IL-5 Receptortargeted therapy currently or within three months prior to Visit 1
Any prior medical conditions or treatment history that the physician deems unfit (including but not restricted to chronic obstructive pulmonary disease, idiopathicpulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis).

Study Design

September 28, 2022

September 30, 2025

Study Description

Asthma, a chronic airway disease characterized by reversible airflow, airway inflammation and hyper responsiveness. A prominent phenotype is eosinophilic asthma, with a prevalence rate of ~50% and characterised by blood eosinophils >300 cells/μL and sputum eosinophils >3%. Inhaled corticosteroids (ICS) have been successful for treatment of mild-to-moderate asthma. However, ~10% of eosinophilic asthmatics remain uncontrolled despite being on high dose oral corticosteroids. This small percentage contributes disproportionately to 80% of asthma healthcare costs [8-10]. As a steroid-sparing strategy, monoclonal antibody (mAb) therapies targeting interleukin (IL)-5 signalling have been developed that are projected to benefit this difficult-to-treat population. Yet, a subset (30-50%) of them remain symptomatic despite being on oral corticosteroids (OCS) and adjunct anti-IL-5 mAb. Anti- eosinophil peroxidase (EPX) Immunoglobulin G (IgG) levels in the airways strongly correlated with the presence of other auto antibodies, in particular the anti-nuclear antibodies (ANAs) as well as various clinical features of asthma severity. Therefore, a better understanding of the underlying pathology with subsequent identification of clinical/molecular biomarkers remains an unmet clinical need for optimal asthma management. Airway autoimmune responses in severe asthma is an important contributor to airway mucus and this can be ameliorated by blocking the IL-4/IL-13 inflammatory axis.

Connect with a study center

The Research Institute of St. Joe's Hamilton
Hamilton, Ontario L8N4A6
Canada
Active - Recruiting

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