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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks from baseline, up to 24 months
Awards & highlights

Study Summary

This trial is testing whether a drug that inhibits IL-17A activation can reduce scarring in the voice box, potentially eliminating the need for surgery.

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.Check my eligibility
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.See study design
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 below
Select...
I have been diagnosed with idiopathic subglottic stenosis.
Select...
I have been diagnosed with idiopathic subglottic stenosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks from baseline, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks from baseline, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

Side effects data

From 2019 Phase 4 trial • 566 Patients • NCT03151551
13%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Injection site reaction
1%
Menometrorrhagia
1%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab
Adalimumab
Ixekizumab Follow-up
Adalimumab Follow-up

Trial Design

1Treatment groups
Experimental Treatment
Group I: TalzExperimental Treatment1 Intervention
All participants receive Talz

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,653 Total Patients Enrolled
Lilly PharmaceuticalCompanyUNKNOWN
Nwanmegha Young, MDPrincipal InvestigatorYale University

Media Library

Taltz (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05309616 — Phase 2
Idiopathic Subglottic Stenosis Research Study Groups: Talz
Idiopathic Subglottic Stenosis Clinical Trial 2023: Taltz Highlights & Side Effects. Trial Name: NCT05309616 — Phase 2
Taltz (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309616 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment currently enrolling participants?

"The most recent updates on clinicaltrials.gov state that patient recruitment for this trial is not occurring at the moment, although it was initially posted in November 2022 and last edited in July 2021. However, there are presently 218 other trials actively seeking out candidates."

Answered by AI

Is Taltz a safe pharmaceutical treatment for individuals to utilize?

"As there is evidence of safety but not efficacy for this Phase 2 trial, Taltz was rated as a '2' on our team's scale."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
California
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Yale New Haven Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

My growth keeps coming back. Took 4 years to get diagnosed and over last 12 month had 9 procedures. Its completely taken control of my life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis
2024. "Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05309616.
~10 spots leftby Nov 2024
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