Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
Primary Purpose
Idiopathic Subglottic Stenosis
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Taltz
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Subglottic Stenosis focused on measuring IL-17a inhibition
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Talz
Arm Description
All participants receive Talz
Outcomes
Primary Outcome Measures
Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire
EQ-5D is a standardized measure of health-related quality of life simple, generic questionnaire. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change in RAND 36-Item short form health-related quality of life survey
The RAND-36 (SF-36) is the most widely used measure of health-related quality of life survey. It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Scoring the RAND 36-Item Health Survey is a two-step process. First, all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Second, items in the same scale are averaged together to create the 8 scale scores.
Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (CCQ)
The CCQ consists of three subdomains: symptoms, functional state and mental state. Items are scored on a Likert scale (range 0-60). The final score is the sum of all items divided by 10; separate scores for all three domains can be calculated. Higher scores indicate a worse health status
Change in Airway, Dyspnea, Voice, and Swallowing (ADVS) Summary Assessment
A disease-specific Patient-Reported Outcome Measure validated surveys Consists of four domains (airway, dyspnea, voice and swallowing) each scored on 4 point Likert scales of functioning. This summary scale will be used to measure efficacy.
Change in Pulmonary function tests (PFT): peak expiratory flow rate in liters/second
Peak expiratory flow rate measures the maximum speed of expiration using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are 80 to 100 percent of the normal predicted peak flow readings indicate good lung function.
Change in PFT: forced expiratory flow rate in liters/second
Forced expiratory flow rate measures the volume of air that can forcibly be blown out in first 1 second, after full inspiration, using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are 80 to 120 percent of the normal predicted peak flow readings indicate good lung function.
Change in PFT: peak inspiratory flow rate in liters/second
Peak inspiratory flow rate measures the maximal flow rate obtained during an inspiratory maneuver using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are >60 L/min indicate good lung function.
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.
Change in degree of stenosis measured by in-office laryngoscopy
Change in degree of stenosis measured by in-office laryngoscopy will be assessed qualitatively every 6 weeks. Degree of stenosis will be assessed as Mild, Moderate or Severe.
Secondary Outcome Measures
Full Information
NCT ID
NCT05309616
First Posted
February 24, 2022
Last Updated
February 9, 2023
Sponsor
Yale University
Collaborators
Lilly PharmaceuticalCompany
1. Study Identification
Unique Protocol Identification Number
NCT05309616
Brief Title
Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
Official Title
Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Lilly PharmaceuticalCompany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Subglottic Stenosis
Keywords
IL-17a inhibition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Talz
Arm Type
Experimental
Arm Description
All participants receive Talz
Intervention Type
Drug
Intervention Name(s)
Taltz
Other Intervention Name(s)
Ixekizumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire
Description
EQ-5D is a standardized measure of health-related quality of life simple, generic questionnaire. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
Monthly up to 24 months
Title
Change in RAND 36-Item short form health-related quality of life survey
Description
The RAND-36 (SF-36) is the most widely used measure of health-related quality of life survey. It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Scoring the RAND 36-Item Health Survey is a two-step process. First, all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Second, items in the same scale are averaged together to create the 8 scale scores.
Time Frame
Every 8 weeks from baseline, up to 24 months
Title
Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (CCQ)
Description
The CCQ consists of three subdomains: symptoms, functional state and mental state. Items are scored on a Likert scale (range 0-60). The final score is the sum of all items divided by 10; separate scores for all three domains can be calculated. Higher scores indicate a worse health status
Time Frame
Monthly up to 24 months
Title
Change in Airway, Dyspnea, Voice, and Swallowing (ADVS) Summary Assessment
Description
A disease-specific Patient-Reported Outcome Measure validated surveys Consists of four domains (airway, dyspnea, voice and swallowing) each scored on 4 point Likert scales of functioning. This summary scale will be used to measure efficacy.
Time Frame
Every 8 weeks from baseline, up to 24 months
Title
Change in Pulmonary function tests (PFT): peak expiratory flow rate in liters/second
Description
Peak expiratory flow rate measures the maximum speed of expiration using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are 80 to 100 percent of the normal predicted peak flow readings indicate good lung function.
Time Frame
Weekly up to 96 weeks
Title
Change in PFT: forced expiratory flow rate in liters/second
Description
Forced expiratory flow rate measures the volume of air that can forcibly be blown out in first 1 second, after full inspiration, using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are 80 to 120 percent of the normal predicted peak flow readings indicate good lung function.
Time Frame
Weekly up to 96 weeks
Title
Change in PFT: peak inspiratory flow rate in liters/second
Description
Peak inspiratory flow rate measures the maximal flow rate obtained during an inspiratory maneuver using a hand held monitor. Patients perform at home PFT weekly and report scores to the study team. Values that are >60 L/min indicate good lung function.
Time Frame
Weekly up to 96 weeks
Title
Number of weeks between operative interventions
Description
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.
Time Frame
From baseline up to 24 months.
Title
Change in degree of stenosis measured by in-office laryngoscopy
Description
Change in degree of stenosis measured by in-office laryngoscopy will be assessed qualitatively every 6 weeks. Degree of stenosis will be assessed as Mild, Moderate or Severe.
Time Frame
Every 6 weeks from baseline up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nwanmegha Young, MD
Phone
(203) 737-1140
Email
Nwanmegha.Young@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nwanmegha Young, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
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