Recruiting

Phase 2

AP01An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Sponsor:

Avalyn Pharma Inc.

Code:

NCT06951217

Conditions

Progressive Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AP01

Study Details

Brief 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.

Conditions

Progressive Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Study ID

NCT06951217

Start date

Apr 17, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.

Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).

Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Exclusion Criteria:

Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

Study Design

Enrollment

340 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label AP01 treatment arm

All 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.

Interventions

AP01

AP01 will be administered open-label via the eFlow Nebulizer System

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 and Locations

Central contacts

Dr. Felix Woodhead, MB BChir,PhD

+44 7999 885973 fwoodhead@avalynpharma.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Principal Investigator:

Tejaswini Kulkarni

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Toby Maher

University of Colorado, Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Joyce Lee, MD

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Principal Investigator:

Raj Karunakara, MD

Piedmont Healthcare, Inc.

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

Amy Case, MD

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Mark Hamblin, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Edward Britt

Johns Hopkins Asthma and Allergy Center

Recruiting

Baltimore, Maryland, United States, 21205

Principal Investigator:

Matthew Lammi, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55901

Principal Investigator:

Andrew Limper, MD

Hannibal Regional Healthcare System, Inc.

Recruiting

Hannibal, Missouri, United States, 63401

Principal Investigator:

Humam Farah, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Maria Padilla, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Claire McGroder, MD

Piedmont HealthCare, PA

Recruiting

Statesville, North Carolina, United States, 28625

Principal Investigator:

Jose Perez, MD

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Jason Thomason

336-765-0383

Principal Investigator:

Jason Thomason, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Nishant Gupta, MD

Summit Health

Recruiting

Bend, Oregon, United States, 97701

Principal Investigator:

Jeremy Feldman, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Ross Summer, MD

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Principal Investigator:

Gerard Criner, MD

Lowcountry Lung and Critical Care, PA

Recruiting

Charleston, South Carolina, United States, 29406

Principal Investigator:

Thomas Kaelin, Jr., DO

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Timothy Whelan, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37204

Principal Investigator:

Justin Hewlett, MD

El Paso Pulmonary Association, P.A.

Recruiting

El Paso, Texas, United States, 79902

Principal Investigator:

Carlo Hatem, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Ivan Rosas

713-798-1000 ivan.rosas@bcm.edu

Principal Investigator:

Ivan Rosas

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Principal Investigator:

Peter Crossno, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Mary Beth Scholand, MD

Inova Healthcare

Recruiting

Falls Church, Virginia, United States, 22042

Principal Investigator:

Vikramjit Khangoora

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Suha Kadura

206-598-4615 skadura@uw.edu

Principal Investigator:

Suha Kadura

Dynamic Drug Advancement

Recruiting

Ajax, Ontario, Canada

Contacts

George Philteos

000-000-000

Principal Investigator:

George Philteos

Research Institute McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Principal Investigator:

Deborah Assayag

CIC Mauricie

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

Contacts

Emilie Millaire

000-000-000

Principal Investigator:

Emilie Millaire

Centre for Lung Health

Recruiting

Vancouver, Vancouver, Canada, V5Z1M9

Contacts

Daniel Marinescu

000-000-000

Principal Investigator:

Daniel Marinescu

More Information

Sponsor

Avalyn Pharma Inc.

Last update posted

Aug 28, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Avalyn Pharma Inc. on 2026-08-28.