An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Avalyn Pharma Inc.
- Study ID
- NCT06951217
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Progressive Pulmonary Fibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AP01 — COMBINATION_PRODUCTAP01 will be administered open-label via the eFlow Nebulizer System
Study Details
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.
Key Dates
- Start date
- Apr 17, 2025
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2031
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 340 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-label AP01 treatment armAll trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.
Primary Outcome Measure
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01). [ Time Frame: Through end of study; average of 6 years ]
Central Contacts
- Dr. Felix Woodhead, MB BChir,PhD+44 7999 885973
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | Tejaswini Kulkarni (PRINCIPAL_INVESTIGATOR) |
| University of Southern California | Los Angeles | California | 90033 | Toby Maher (PRINCIPAL_INVESTIGATOR) |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | Joyce Lee Joyce Lee, MD (PRINCIPAL_INVESTIGATOR) |
| Renstar Medical Research | Ocala | Florida | 34470 | Raj Karunakara Raj Karunakara, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont Healthcare, Inc. | Atlanta | Georgia | 30309 | Amy Case Amy Case, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland | Baltimore | Maryland | 21201 | Edward Britt (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Rochester | Rochester | Minnesota | 55901 | Andrew Limper Sam Nascak Andrew Limper, MD (PRINCIPAL_INVESTIGATOR) |
| Hannibal Regional Healthcare System, Inc. | Hannibal | Missouri | 63401 | Humam Farah, MD Humam Farah, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | Claire McGroder Claire McGroder, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Maria Padilla Maria Padilla, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont HealthCare, PA | Statesville | North Carolina | 28625 | Jose Perez Jose Perez, MD (PRINCIPAL_INVESTIGATOR) |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | Jason Thomason 336-765-0383 Jason Thomason, MD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati | Cincinnati | Ohio | 45267 | Nishant Gupta Nishant Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Kansas Medical Center | Kansas | Ohio | 66160 | Mark Hamblin Mark Hamblin, MD (PRINCIPAL_INVESTIGATOR) |
| Summit Health | Bend | Oregon | 97701 | Jeremy Feldman, MD Jeremy Feldman, MD (PRINCIPAL_INVESTIGATOR) |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Gerard Criner, MD Gerard Criner, MD (PRINCIPAL_INVESTIGATOR) |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Ross Summer Ross Summer, MD (PRINCIPAL_INVESTIGATOR) |
| Lowcountry Lung and Critical Care, PA | Charleston | South Carolina | 29406 | Thomas Kaelin, Jr, DO Thomas Kaelin, Jr., DO (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Timothy Whelan Timothy Whelan, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | Justin Hewlett, MD Justin Hewlett, MD (PRINCIPAL_INVESTIGATOR) |
| El Paso Pulmonary Association, P.A. | El Paso | Texas | 79902 | Carlo Hatem, MD Carlo Hatem, MD (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84107 | Peter Crossno, MD Peter Crossno, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Healthcare | Falls Church | Virginia | 22042 | Vikramjit Khangoora (PRINCIPAL_INVESTIGATOR) |
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