Inhibition of IL-17A to treat idiopathic subglottic stenosis
Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis
This study is testing if the drug Taltz can help people with idiopathic subglottic stenosis by reducing scarring and the need for surgeries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05309616 on ClinicalTrials.gov |
What this trial studies
This phase 2 study investigates the effects of the biologic drug Taltz, which inhibits IL-17A activation, on patients with idiopathic subglottic stenosis. The goal is to reduce scar fibroblast proliferation, potentially decreasing the need for invasive surgeries. The study is a single arm, open-label design, meaning all participants will receive the treatment. It aims to improve the quality of life for patients by minimizing surgical interventions and associated recovery times.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic subglottic stenosis who are willing to comply with study procedures.
Not a fit: Patients with a history of active or latent tuberculosis, inflammatory bowel disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for invasive surgeries in patients with idiopathic subglottic stenosis.
How similar studies have performed: Other studies targeting IL-17A inhibition have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Nwanmegha Young, MD — Yale University
- Study coordinator: Nwanmegha Young, MD
- Email: Nwanmegha.Young@yale.edu
- Phone: (203) 737-1140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.