10 Participants Needed

Taltz for Laryngostenosis

NY
Overseen ByNwanmegha Young, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Taltz can help people with idiopathic subglottic stenosis, a condition where the airway below the vocal cords narrows without a known cause. Researchers aim to determine if Taltz can reduce scar tissue growth in the airway, potentially helping patients avoid or undergo fewer surgeries. The trial seeks participants diagnosed with idiopathic subglottic stenosis who are willing to join the study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Taltz is likely to be safe for humans?

Research has shown that Taltz, also known as ixekizumab, maintains a consistent safety record across various studies. In trials involving patients with conditions like psoriasis and psoriatic arthritis, the most common side effects were mild, including injection site reactions, colds, nausea, and fungal infections. Serious side effects occurred rarely, and overall safety remained stable even with long-term use.

This suggests that Taltz is generally well-tolerated. However, because this new study focuses on laryngostenosis (a throat condition), monitoring for any potential side effects specific to this condition is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for laryngostenosis, which typically involve surgical procedures or steroid injections to manage the condition, Taltz offers a unique approach by targeting the underlying inflammation. Taltz is an IL-17A inhibitor, a type of medication that specifically blocks a protein involved in inflammatory responses, which might help reduce the narrowing of the larynx without invasive methods. Researchers are excited about Taltz because it has the potential to provide a non-surgical option that directly addresses inflammation, possibly leading to better outcomes with fewer side effects.

What evidence suggests that Taltz might be an effective treatment for laryngostenosis?

Studies have shown that Taltz (also known as ixekizumab) effectively treats various conditions by targeting IL-17A, a protein that causes inflammation. For instance, 76% of patients with psoriatic arthritis experienced significant improvement after one year. In psoriasis, Taltz led to complete skin clearance in many cases, with 83% of those with scalp psoriasis achieving this outcome. Although these studies focus on conditions other than laryngostenosis, they demonstrate Taltz’s ability to reduce inflammation, which is crucial in preventing scarring and tissue thickening. This suggests it might help reduce scar tissue growth in laryngostenosis.16789

Who Is on the Research Team?

NY

Nwanmegha Young, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.
See 1 more

Exclusion Criteria

My condition affects my vocal cords.
I have a history of inflammatory bowel disease.
I have had tuberculosis in the past.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Taltz
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TalzExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Lilly PharmaceuticalCompany

Collaborator

Trials
1
Recruited
10+

Citations

Efficacy and Safety of Ixekizumab Through 5 Years in ...Conclusions. The results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in ...
Treatment Efficacy | Rheumatology PsA | Taltz (ixekizumab)In SPIRIT-P1, in an mNRI analysis of patients receiving Taltz, ACR20 results were 76% at week 52, 71% at week 108, and 70% at week 156, ACR50 results were 60% ...
Comparative Analysis of Ixekizumab Effectiveness with and ...Both biologic-naïve and biologic-experienced patients demonstrated similar efficacy, and drug retention rates were high at 96%, with minimal discontinuations ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37434099/
Data from the United States Taltz Customer Support ProgramPatient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after ...
New Data at EADV 2020 Confirm Taltz® (ixekizumab ...Complete clearance: With Taltz, 83%, 73% and 89% of patients reported complete clearance in scalp, nail and palmoplantar psoriasis, respectively ...
Safety Data | Dermatology | Taltz (ixekizumab) - Eli LillyThe most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea ...
Safety results of ixekizumab with 1822.2 patient-years ...The findings of this integrated safety analysis in patients with psoriatic arthritis are consistent with the known safety profile of ixekizumab.
Long-term safety of Ixekizumab in adults with psoriasis ...We report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO), ...
What are the long-term safety results of Taltz® (ixekizumab) in ...Exposure-adjusted incidence rate for treatment-emergent adverse events and serious adverse events remained stable or decreased over time in ixekizumab ...
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