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

NCT ID: NCT05309616

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2026-04-30

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.

Conditions

Idiopathic Subglottic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Talz

All participants receive Talz

Group Type: EXPERIMENTAL

Taltz

Intervention Type: DRUG

Participants will receive160 mg (two 80 mg injections) at week 0, followed by 80 mg at weeks 2,4,6,8,10,12 and then 80 mg every 4 weeks

Interventions

Taltz

Participants will receive160 mg (two 80 mg injections) at week 0, followed by 80 mg at weeks 2,4,6,8,10,12 and then 80 mg every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Ixekizumab

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lilly PharmaceuticalCompany

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nwanmegha Young, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nwanmegha Young, MD

Role: CONTACT

Nwanmegha.Young@yale.edu

(203) 737-1140

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000031202

Identifier Type: -

Identifier Source: org_study_id