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ACTIVE NOT RECRUITING

NCT06329401

PHASE2

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Sponsor: Avalyn Pharma Inc.

View on ClinicalTrials.gov

Summary

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

398

Start Date

2024-04-03

Completion Date

2027-06

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Pulmonary Fibrosis Progressive Pulmonary Fibrosis Pulmonary Fibrosis Secondary to Systemic Sclerosis Pulmonary Fibrosis, Interstitial Lung Disease Interstitial Lung Disease Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)Interstitial Lung Disease in Patients With Rheumatoid Arthritis Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere Hypersensitivity Pneumonitis Interstitial Lung Disease With Systemic Sclerosis

Interventions

DRUG

AP01

Oral inhalation solution

OTHER

Placebo

Placebo oral inhalation solution

Inclusion Criteria: * Participant meets criteria for PPF, as follows: * In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator): 1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments 2. Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria: * Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR * Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example: * Increased extent or severity of traction bronchiectasis and bronchiolectasis * New ground-glass opacity with traction bronchiectasis * New fine reticulation * Increased extent or increased coarseness of reticular abnormality * New or increased honeycombing * Increased lobar volume loss 3. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist * Meeting all of the following criteria during the Screening Period: a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits). • For subjects already on background therapy (nintedanib or nerandomilast 18 mg twice daily \[up to 30% of subjects\]): Must have been on background therapy for at least 12 weeks prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued background therapy prior to Screening: Must have been off for a minimum of 12 weeks. Exclusion Criteria: * Current treatment with oral pirfenidone or nerandomilast 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening. * Elevated liver enzymes and liver injury at Screening defined as: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN) 2. Bilirubin \>2.0 x ULN * Renal disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once. * Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary. * Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process. * Significant clinical worsening of PPF between Screening Visit 1 and Visit 3 * Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.

Locations (154)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic- Scottsdale

Scottsdale, Arizona, United States

University of Southern California

Los Angeles, California, United States

Cedars-Sinai

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Newport Native MD, Inc.

Newport Beach, California, United States

Paradigm Clinical Research - Redding

Redding, California, United States

University of California - San Francisco

San Francisco, California, United States

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

National Jewish Health

Denver, Colorado, United States

UCONN Health

Farmington, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Clinical Site Partners, LCC

Leesburg, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Site Partners

Winter Park, Florida, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Endeavor Health

Evanston, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Hannibal Regional Healthcare System

Hannibal, Missouri, United States

Northern Westchester Hospital

Mount Kisco, New York, United States

Northwell Health - Mount Kisco

Mount Kisco, New York, United States

NYU Langone Health

New York, New York, 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

Montefiore Medical Center

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Piedmont HealthCare, PA

Statesville, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Oregon Clinic Pulmonary West

Beaverton, Oregon, United States

Summit Health

Bend, Oregon, United States

The Oregon Clinic Pulmonary East

Portland, Oregon, United States

The Oregon Clinic Pulmonary West

Portland, Oregon, United States

The Pennsylvania State University

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Lowcountry Lung and Critical Care

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, United States

Vanderbilt Lung Institute

Nashville, Tennessee, United States

Baylor Scott & White Research Institute, Baylor University Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

El Paso Pulmonary Association

El Paso, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The University of Texas Health Science Center

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center, PA

McKinney, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

Inova Healthcare

Falls Church, Virginia, United States

University of Washington

Seattle, Washington, United States

Fundacion Respirar

Buenos Aires, Buenos Aires, Argentina

CINME

Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Ave Pulmo, Fundacion Enfisema

Mar del Plata, Buenos Aires, Argentina

Clinica Monte Grande

Monte Grande, Buenos Aires, Argentina

Centro Respiratorio Quilmes

Quilmes, Buenos Aires, Argentina

Instituto de Medicina Respiratoria

Córdoba, Córdoba Province, Argentina

CIMER Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Nepean Lung & Sleep

Kingswood, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Macquarie University Clinical Trials Unit

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Institute for Respiratory Health

Nedlands, Perth West Australia, Australia

Wallace Street Specialist Centre/Lung Research QLD Pty Ltd

Brisbane, Queensland, Australia

Lung Research Victoria

Footscray, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

Canberra Hospital

Canberra, Australia

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

Vancouver General Hospital

Vancouver, British Columbia, Canada

Dynamic Drug Advancement

Ajax, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Research Institute McGill University Health Center

Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

Québec, Quebec, Canada

CIC Mauricie

Trois-Rivières, Quebec, Canada

CHU de Rennes

Rennes, Cedex NA, France

CHU Tours

Tours, Indre et Loire, France

Robert Schuman Hospital UNEOS

Metz, Lorraine, France

Louis Pradel Hospital

Lyon, Lyon, France

University of Montpellier

Montpellier, Montpellier, France

CHU Angers

Angers, France

APHP - Hopital Bicetre

Le Kremlin-Bicêtre, France

Hôpital Paris St Jozeph

Paris, France

Hôpital Haut-Lévêque

Pessac, France

Pneumologisches Studienzentrum München-West

Munich, Bavaria, Germany

Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie

München, Bavaria, Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

And 54 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (154)