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NCT06951217 · ClinicalTrials.gov registry record · Phase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
A Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, sponsored by Avalyn Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT06951217: Recruiting Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, sponsored by Avalyn Pharma.
NCT06951217 is a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis that is actively recruiting participants, run by Avalyn Pharma. The registered enrollment target is 340 participants, below the 454-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06951217, a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, is actively recruiting participants, sponsored by Avalyn Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.
Primary Outcome
The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), ox
Conditions Studied
Interventions
- COMBINATION_PRODUCT AP01
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University - New York
North Carolina
- Piedmont HealthCare, PA - Statesville
- Southeastern Research Center - Winston-Salem
Ohio
- University of Cincinnati - Cincinnati
- The University of Kansas Medical Center - Kansas
Pennsylvania
- Thomas Jefferson University - Philadelphia
- Temple University Hospital - Philadelphia
South Carolina
- Lowcountry Lung and Critical Care, PA - Charleston
- Medical University of South Carolina - Charleston
Colorado
- University of Colorado, Anschutz Medical Campus - Aurora
Florida
- Renstar Medical Research - Ocala
Georgia
- Piedmont Healthcare, Inc. - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What NCT06951217 shows while recruiting
NCT06951217 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 454-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Idiopathic Pulmonary Fibrosis (IPF) appearing as the primary indexed condition, and to 1 intervention - of which AP01 is the first listed.
NCT06951217 names 20 study sites across 15 states, led by New York, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT06951217 about?
NCT06951217 is a clinical study titled "An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)". This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE...
What is the current status of trial NCT06951217?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2025-04-17. Estimated completion is 2031-12-31.
What conditions does trial NCT06951217 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis.
What interventions are being tested in trial NCT06951217?
The interventions under investigation include: AP01 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06951217?
This trial is sponsored by Avalyn Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951217 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis (IPF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06951217's enrollment target sits among peer trials
340 4th of 8 higher than 5 of 8 other Idiopathic Pulmonary Fibrosis (IPF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis (IPF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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