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NCT06951217PHASE2Recruiting

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

Avalyn Pharma Inc.

Start Date

4/17/2025

Completion Date

12/31/2031

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.

Detailed Description

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System. The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug. A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

COMBINATION_PRODUCT

AP01

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Conditions

Progressive Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

University of Southern California

Los Angeles, California 90033

United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado 80045

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Piedmont Healthcare, Inc.

Atlanta, Georgia 30309

United States

The University of Kansas Medical Center

Kansas City, Kansas 66160

United States

University of Maryland

Baltimore, Maryland 21201

United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland 21205

United States

Mayo Clinic Rochester

Rochester, Minnesota 55901

United States

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri 63401

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Columbia University

New York, New York 10032

United States

Piedmont HealthCare, PA

Statesville, North Carolina 28625

United States

Southeastern Research Center

Winston-Salem, North Carolina 27103

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

Summit Health

Bend, Oregon 97701

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Temple University Hospital

Philadelphia, Pennsylvania 19140

United States

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina 29406

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37204

United States

El Paso Pulmonary Association, P.A.

El Paso, Texas 79902

United States

Intermountain Medical Center

Murray, Utah 84107

United States

University of Utah

Salt Lake City, Utah 84108

United States

Inova Healthcare

Falls Church, Virginia 22042

United States

Westmead Hospital

Westmead, New South Wales 2145

Australia

The Queen Elizabeth Hospital

Woodville South, South Australia 5011

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

Research Institute McGill University Health Center

Montreal, Quebec H4A 3J1

Canada

CIC Mauricie

Trois-Rivières, Quebec G8T 7A1

Canada

Centre for Lung Health

Vancouver, Vancouver V5Z1M9

Canada

Fakultni Thomayerove nemocnice

Praha Klanovice,

Czechia

University of Montpellier

Montrevel-en-Bresse, Montpellier 34090

France

Centre Hospitalier Universitaire d'Angers

Angers, 49933

France

Medizinische Hochschule Hannover

Hanover, Lower Saxony 30625

Germany

Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

Pavia, Lombardy 27100

Italy

St Antonius Hospital

Nieuwegein,

Netherlands

Greenlane Clinical Centre

Auckland, Auckland

New Zealand

Bay of Plenty Clinical Trials Unit

Tauranga, Tauranga 3112

New Zealand

Dunedin Hospital

Dunedin, 9016

New Zealand

Waikato Hospital

Hamilton,

New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, 80211

Poland

Department of Pneumology of the University Hospital No 1

Lodz, 90315

Poland

Hospital Gregorio Marañon

Madrid, Madrid

Spain

Hull University Teaching Hospital

Cottingham, East Yorkshire HU16 5JQ

United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY

United Kingdom

Leicester Biomedical Research Centre

Leicester,

United Kingdom