Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of weeks between operative interventions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Talz
All participants receive Talz
干预措施: Taltz (Drug)
结局指标
主要结局
Number of weeks between operative interventions
时间窗: From baseline up to 12 months.
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.
次要结局
- Change in PFT: peak inspiratory flow rate in liters/second(Weekly up to 12 months)
- Change in degree of stenosis measured by in-office laryngoscopy(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)
- Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire(Every 12 weeks up to 12 months)
- Change in PFT: forced expiratory flow rate in liters/second(Weekly 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 Pulmonary function tests (PFT): peak expiratory flow rate in liters/second(Weekly up to 12 months)