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NCT05153668 · ClinicalTrials.gov registry record · Early Phase 1

Everolimus Trial in Laryngotracheal Stenosis

A Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis, sponsored by Johns Hopkins University.

Completed
Registry status
Early Phase 1
Development phase
8
Enrollment target
1
Study location

NCT05153668 is a Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis that has completed, run by Johns Hopkins University. The registered enrollment target is 8 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT05153668, a Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Early Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. The proposed Adjuvant EveRolimus Outcomes (AERO) trial is proof-of-concept study using the immunosuppressant drug, everolimus, to reduce the number of surgeries for patients with idiopathic Subglottic Stenosis (iSGS). Success with the AERO trial will allow for everolimus to be used in subsequent larger trials of participants with laryngotracheal stenosis and could lead to everolimus being the first FDA approved medical treatment for iSGS.

Interventions

  • DRUG Everolimus Oral Tablet

Study Locations (1)

Maryland

  • Johns Hopkins Outpatient Center - Baltimore

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2022-09-30
Est. Completion 2025-10-23
Phase Early Phase 1

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT05153668

The ClinicalTrials.gov registry entry for NCT05153668 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Idiopathic Subglottic Tracheal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Everolimus Oral Tablet is the first listed.

NCT05153668 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05153668 about?

NCT05153668 is a clinical study titled "Everolimus Trial in Laryngotracheal Stenosis". Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. The proposed Adjuvan...

What is the current status of trial NCT05153668?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2022-09-30. Estimated completion is 2025-10-23.

What conditions does trial NCT05153668 study?

This clinical trial studies the following conditions: Idiopathic Subglottic Tracheal Stenosis.

What interventions are being tested in trial NCT05153668?

The interventions under investigation include: Everolimus Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT05153668?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05153668 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.