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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

2026-10-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

AP01

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

Locations (85)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Southern California

Los Angeles, California, United States

Newport Native MD, Inc.

Newport Beach, California, United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Renstar Medical Research

Ocala, Florida, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri, United States

Weill Cornell

New York, New York, 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

Summit Health

Bend, Oregon, United States

The Oregon Clinic Pulmonary East

Portland, 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

Baylor College of Medicine

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah

Salt Lake City, Utah, United States

Inova Healthcare

Falls Church, Virginia, United States

University of Washington

Seattle, Washington, United States

CIMER Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Respirar

Buenos Aires, Argentina

Clinica Monte Grande

Buenos Aires, Argentina

Instituto Ave Pulmo, Fundacion Enfisema

Buenos Aires, Argentina

Centro Respiratorio Quilmes

Buenos Aires, Argentina

CINME

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Macquarie University Clinical Trials Unit

Macquarie Park, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Wallace Street Specialist Centre/Lung Research QLD Pty Ltd

Brisbane, Queensland, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Alfred Health

Melbourne, Victoria, 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

Research Institute McGill University Health Center

Montreal, Quebec, 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

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

Berlin, State of Berlin, Germany

Studienzentrum Dr. Claus Keller

Frankfurt, Germany

Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

Pavia, Lombardy, Italy

HUMANITAS Research Hospital

Milan, Italy

Ospedale San Giuseppe/ MultiMedica SPA

Milan, Italy

St Antonius Hospital

Nieuwegein, Netherlands

Greenlane Clinical Centre

Auckland, Auckland, New Zealand

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Bay of Plenty Clinical Trials Unit

Tauranga, Tauranga, 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

Prywatny Gabinet Lekarski Ginekologia I Połoznictwo Ultrasonografia

Lodz, Łódź Voivodeship, Poland

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Hospital Universitary de Bellvitge

Barcelona, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hull University Teaching Hospital

Cottingham, East Yorkshire, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, South East England, United Kingdom

ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

Birmingham, West Midlands, United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Leicester Biomedical Research Centre

Leicester, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom