Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

Yale University

Status and phase: Active, not recruiting; Phase 2

Conditions: Idiopathic Subglottic Stenosis

Treatments: Drug: Taltz

Study type: Interventional

Funder types: Other

Identifiers

NCT05309616

No NIH funding (Other Identifier)

2000031202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Talz

Experimental group

Description:

All participants receive Talz

Treatment:

Drug: Taltz