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

NCT05309616 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 2000031202No NIH funding
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Subglottic Stenosis

Keywords

IL-17a inhibition

Outcome Measures

Primary Outcomes (1)

• Number of weeks between operative interventions

  The number of weeks between operative interventions will be counted. Intervention is performed once stenosis related symptoms interfere with daily life. Participants intervals will be compared to their own baseline and national databases (pre-treatment) to assess if IL-17A inhibition prolongs the interval between interventions with prolonged intervals indicating a slower progression to re-stenosis.

  From baseline up to 12 months.

Secondary Outcomes (8)

• Change in degree of stenosis measured by in-office laryngoscopy

  Every 12 weeks up to 12 months

• Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire

  Every 12 weeks up to 12 months

• Change in RAND 36-Item short form health-related quality of life survey

  Every 12 weeks up to 12 months

• Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (CCQ)

  Every 12 weeks up to 12 months

• Change in Airway, Dyspnea, Voice, and Swallowing (ADVS) Summary Assessment

  Every 12 weeks up to 12 months

Study Arms (1)

Talz

EXPERIMENTAL

All participants receive Talz

Drug: Taltz

Interventions

Taltz 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

Also known as: Ixekizumab

Talz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Lilly PharmaceuticalCompany: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Idiopathic subglottic tracheal stenosis

Interventions

ixekizumab

Study Officials

• Nwanmegha Young, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 4, 2022
• Study Start: February 20, 2025
• Primary Completion: May 19, 2026
• Study Completion: May 19, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)