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Monoclonal Antibodies
Taltz for Laryngostenosis
Phase 2
Waitlist Available
Led By Nwanmegha Young, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
diagnosis of idiopathic subglottic stenosis
Diagnosis of idiopathic subglottic stenosis
Must not have
Disease involving the vocal cords
History of inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks from baseline, up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if Taltz can help patients with idiopathic subglottic stenosis by reducing inflammation and scar tissue in their airways. This could decrease their need for repeated surgeries.
Who is the study for?
This trial is for individuals with idiopathic subglottic stenosis, a narrowing of the airway below the vocal cords. Participants must consent to study procedures and be available throughout the study. It excludes those with tuberculosis history, pregnant or lactating women, people with inflammatory bowel disease, or allergies to Taltz.
What is being tested?
The trial tests if Taltz can inhibit IL-17A activation to reduce scar tissue growth in patients' airways, potentially decreasing the need for repeated surgeries.
What are the potential side effects?
Taltz may cause side effects such as injection site reactions (like redness), increased risk of infections due to immune system suppression, and possibly allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with idiopathic subglottic stenosis.
Select...
I have been diagnosed with idiopathic subglottic stenosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition affects my vocal cords.
Select...
I have a history of inflammatory bowel disease.
Select...
I have had tuberculosis in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks from baseline, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks from baseline, up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Airway, Dyspnea, Voice, and Swallowing (ADVS) Summary Assessment
Chronic Obstructive Airway Disease
Change in European Quality of Life-Five Dimensions (EQ-5D) Questionnaire
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TalzExperimental Treatment1 Intervention
All participants receive Talz
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Idiopathic Subglottic Stenosis (iSGS) often involve managing inflammation and reducing scar tissue formation. One promising approach, as studied with the drug Taltz, involves inhibiting IL-17A activation.
IL-17A is a cytokine that contributes to inflammation and the proliferation of scar fibroblasts. By inhibiting IL-17A, the treatment aims to reduce fibroblast activity, thereby decreasing scar tissue formation and the need for invasive surgeries.
This targeted approach is significant for iSGS patients as it offers a potential reduction in airway obstructions and an improvement in overall quality of life.
Research advances in airway remodeling in asthma: a narrative review.Challenging the paradigm: moving from umbrella labels to treatable traits in airway disease.Effect of sublingual immunotherapy on antigen-induced bronchial and nasal inflammation in mice.
Research advances in airway remodeling in asthma: a narrative review.Challenging the paradigm: moving from umbrella labels to treatable traits in airway disease.Effect of sublingual immunotherapy on antigen-induced bronchial and nasal inflammation in mice.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,919 Previous Clinical Trials
3,040,345 Total Patients Enrolled
Lilly PharmaceuticalCompanyUNKNOWN
Nwanmegha Young, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition affects my vocal cords.I have a history of inflammatory bowel disease.I have been diagnosed with idiopathic subglottic stenosis.I am willing and able to follow the study's procedures and be available for its duration.I have been diagnosed with idiopathic subglottic stenosis.I have had tuberculosis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Talz
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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