Taltz for Laryngostenosis

Overseen by Nwanmegha Young, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Yale University

Must not be taking: ACE inhibitors, NSAIDs

Disqualifiers: Tuberculosis, Inflammatory bowel disease, Pregnancy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that trigger angioedema, like ACE inhibitors (e.g., Lisinopril) or NSAIDs.

Research Team

Nwanmegha Young, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

My condition affects my vocal cords.

I have a history of inflammatory bowel disease.

I have had tuberculosis in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Taltz to inhibit IL-17A activation, aiming to decrease scar fibroblast proliferation and reduce the need for surgeries

12 months

In-office laryngoscopy every 6 weeks, health-related quality of life assessments every 12 weeks, and weekly pulmonary function tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Taltz (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Talz Experimental Treatment 1 Intervention

All participants receive Talz

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

Lilly PharmaceuticalCompany

Collaborator

Trials

1

Recruited

10+