Clinical trial NCT05309616: Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
Official title: Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Subglottic Stenosis
Keywords: IL-17a inhibition
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Lilly PharmaceuticalCompany
First posted: 2022-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 2 study is to examine if inhibiting IL-17A activation using the biologic drug Taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries.

Detailed description: The purpose of this phase 2 study is to examine if inhibiting IL-17A activation using the biologic drug Taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries. Inhibition of the IL-17A pathway can slow or reverse the inflammation causing airway narrowing in patients with idiopathic subglottic stenosis. This would have a significant impact on quality of life for patients living with this diagnosis as it may help them to avoid frequent surgical procedures, recoveries and associated costs.

This is a single arm, open-label study where all participants will receive drug. The study population is patients with a documented diagnosis of idiopathic subglottic stenosis who are followed at Yale New Haven Hospital.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* diagnosis of idiopathic subglottic stenosis

Exclusion Criteria:

* History of active or latent tuberculosis infection
* History of inflammatory bowel disease
* Pregnancy or lactation
* Known allergic reactions to study drug
* Disease involving the vocal cords
* Individuals who are taking drugs known to trigger angioedema, including use acquired angioedema from drugs such as ACE inhibitors (e.g. Lisinopril) and nonsteroidal anti-inflammatory drugs (NSAIDs) and individuals with a history of other forms of angioedema such as hereditary and Clesterase deficiency

Primary outcomes:
measure: Number of weeks between operative interventions
timeFrame: From baseline up to 12 months.
Secondary outcomes:
measure: Change in degree of stenosis measured by in-office laryngoscopy
timeFrame: Every 12 weeks up to 12 months
measure: Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire
timeFrame: Every 12 weeks up to 12 months
measure: Change in RAND 36-Item short form health-related quality of life survey
timeFrame: Every 12 weeks up to 12 months
measure: Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (CCQ)
timeFrame: Every 12 weeks up to 12 months
measure: Change in Airway, Dyspnea, Voice, and Swallowing (ADVS) Summary Assessment
timeFrame: Every 12 weeks up to 12 months
measure: Change in Pulmonary function tests (PFT): peak expiratory flow rate in liters/second
timeFrame: Weekly up to 12 months
measure: Change in PFT: forced expiratory flow rate in liters/second
timeFrame: Weekly up to 12 months
measure: Change in PFT: peak inspiratory flow rate in liters/second
timeFrame: Weekly up to 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Nwanmegha Young, MD
role: PRINCIPAL_INVESTIGATOR
References: