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RECRUITING

NCT06951217

PHASE2

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

Sponsor: Avalyn Pharma Inc.

View on ClinicalTrials.gov

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.

Official title: A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2025-04-17

Completion Date

2031-12-31

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Progressive Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)

Interventions

COMBINATION_PRODUCT

AP01

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

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.

Locations (44)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Renstar Medical Research

Ocala, Florida, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

Piedmont HealthCare, PA

Statesville, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The University of Kansas Medical Center

Kansas, Ohio, United States

Summit Health

Bend, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

El Paso Pulmonary Association, P.A.

El Paso, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Westmead Hospital

Westmead, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

The Prince Charles Hospital (TPCH)

Chermside, Australia

Lung & Sleep Victoria

Footscray, Australia

Respiratory Clinical Trials PTY Ltd

Kent Town, Australia

Nepean Lung & Sleep

Kingston, Australia

Univ of Western Australia / Institute for Respiratory Health

Nedlands, Australia

John Hunter Hospital

New Lambton Heights, Australia

Dynamic Drug Advancement

Ajax, Ontario, Canada

CIC Mauricie

Trois-Rivières, Quebec, Canada

Centre for Lung Health

Vancouver, Vancouver, Canada

Fakultni Thomayerove nemocnice

Praha Klanovice, Czechia

University of Montpellier

Montrevel-en-Bresse, Montpellier, France

Centre Hospitalier Universitaire d'Angers

Angers, France

Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

Pavia, Lombardy, Italy

St Antonius Hospital

Nieuwegein, Netherlands

Greenlane Clinical Centre

Auckland, Auckland, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Waikato Hospital

Hamilton, New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Department of Pneumology of the University Hospital No 1

Lodz, Poland

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Leicester Biomedical Research Centre

Leicester, United Kingdom