TrialPath
← Back to searchRecruiting

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

NCT06329401 · Avalyn Pharma Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Eligibility criteria
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 nintedanib (up to 30% of subjects): Must have been on nintedanib for at least 6 months prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued nintedanib prior to Screening: Must have been off of nintedanib for a minimum of 12 weeks. Exclusion Criteria: * Current treatment with oral pirfenidone 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 * 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.
Study design
Enrollment target: 375 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-04-03
Estimated completion: 2027-06
Last updated: 2026-04-06
Interventions
Drug: AP01Other: Placebo
Primary outcomes
  • To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) (Week 52)
Sponsor
Avalyn Pharma Inc. · industry
With: DevPro Biopharma
Contacts & investigators
ContactCraig S. Conoscenti, MD · contact · cconoscenti@avalynpharma.com · 206-707-0304
ContactDaniele Tompkins · contact · dtompkins@devprobiopharma.com · 973-983-3700
InvestigatorAvalyn Pharma, Inc. · study_director, Avalyn Pharma Inc.
All locations (152)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Mayo Clinic- ScottsdaleRecruiting
Scottsdale, Arizona, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Cedars-SinaiRecruiting
Los Angeles, California, United States
UCLARecruiting
Los Angeles, California, United States
Newport Native MD, Inc.Recruiting
Newport Beach, California, United States
Paradigm Clinical Research - ReddingRecruiting
Redding, California, United States
University of California - San FranciscoRecruiting
San Francisco, California, United States
University of Colorado, Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
National Jewish HealthRecruiting
Denver, Colorado, United States
UCONN HealthRecruiting
Farmington, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Clinical Site Partners, LCCRecruiting
Leesburg, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
Clinical Site PartnersRecruiting
Winter Park, Florida, United States
Piedmont Healthcare, Inc.Recruiting
Atlanta, Georgia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Endeavor HealthRecruiting
Evanston, Illinois, United States
Loyola University Medical CenterRecruiting
Maywood, Illinois, United States
The University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
University of MarylandRecruiting
Baltimore, Maryland, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Hannibal Regional Healthcare SystemRecruiting
Hannibal, Missouri, United States
Northwell Health - Mount KiscoRecruiting
Mount Kisco, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Weill CornellRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Columbia UniversityRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Piedmont HealthCare, PARecruiting
Statesville, North Carolina, United States
AccellacareRecruiting
Wilmington, North Carolina, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Summit HealthRecruiting
Bend, Oregon, United States
The Oregon Clinic Pulmonary EastRecruiting
Portland, Oregon, United States
The Oregon Clinic Pulmonary WestRecruiting
Portland, Oregon, United States
The Pennsylvania State UniversityRecruiting
Hershey, Pennsylvania, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical CareRecruiting
Charleston, South Carolina, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Clinical Trials Center of Middle TennesseeRecruiting
Franklin, Tennessee, United States
Vanderbilt Lung InstituteRecruiting
Nashville, Tennessee, United States
Baylor Scott & White Research Institute, Baylor University Medical CenterRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
El Paso Pulmonary AssociationRecruiting
El Paso, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
The University of Texas Health Science CenterRecruiting
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center, PARecruiting
McKinney, Texas, United States
Intermountain Medical CenterRecruiting
Murray, Utah, United States
University of Utah HealthRecruiting
Salt Lake City, Utah, United States
Inova HealthcareRecruiting
Falls Church, Virginia, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Fundacion RespirarRecruiting
Buenos Aires, Buenos Aires, Argentina
CINMERecruiting
Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos AiresRecruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Ave Pulmo, Fundacion EnfisemaRecruiting
Mar del Plata, Buenos Aires, Argentina
Clinica Monte GrandeRecruiting
Monte Grande, Buenos Aires, Argentina
Centro Respiratorio QuilmesRecruiting
Quilmes, Buenos Aires, Argentina
Instituto de Medicina RespiratoriaRecruiting
Córdoba, Córdoba Province, Argentina
CIMER Centro Integral de Medicina RespiratoriaRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones En Patologias RespiratoriasRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Royal Prince Alfred HospitalRecruiting
Camperdown, New South Wales, Australia
Nepean Lung & SleepRecruiting
Kingswood, New South Wales, Australia
John Hunter HospitalRecruiting
New Lambton, New South Wales, Australia
Macquarie University Clinical Trials UnitRecruiting
Sydney, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Institute for Respiratory HealthRecruiting
Nedlands, Perth West Australia, Australia
Wallace Street Specialist Centre/Lung Research QLD Pty LtdRecruiting
Brisbane, Queensland, Australia
Lung Research VictoriaRecruiting
Footscray, Victoria, Australia
Alfred HealthRecruiting
Melbourne, Victoria, Australia
Canberra HospitalRecruiting
Canberra, Australia
UZ LeuvenRecruiting
Leuven, Belgium
CHU de LiègeRecruiting
Liège, Belgium
Vancouver General HospitalRecruiting
Vancouver, British Columbia, Canada
Dynamic Drug AdvancementRecruiting
Ajax, Ontario, Canada
St. Joseph's Healthcare HamiltonRecruiting
Hamilton, Ontario, Canada
Research Institute McGill University Health CenterRecruiting
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université LavalRecruiting
Québec, Quebec, Canada
CIC MauricieRecruiting
Trois-Rivières, Quebec, Canada
CHU de RennesRecruiting
Rennes, Cedex NA, France
CHU ToursRecruiting
Tours, Indre et Loire, France
Robert Schuman Hospital UNEOSRecruiting
Metz, Lorraine, France
Louis Pradel HospitalRecruiting
Lyon, Lyon, France
University of MontpellierRecruiting
Montpellier, Montpellier, France
CHU AngersRecruiting
Angers, France
APHP - Hopital BicetreRecruiting
Le Kremlin-Bicêtre, France
Hôpital Paris St JozephRecruiting
Paris, France
Hôpital Haut-LévêqueRecruiting
Pessac, France
Pneumologisches Studienzentrum München-WestRecruiting
Munich, Bavaria, Germany
Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische OnkologieRecruiting
München, Bavaria, Germany
RoMed Klinikum RosenheimRecruiting
Rosenheim, Bavaria, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Lower Saxony, Germany
Studienzentrum Dr. Claus KellerRecruiting
Frankfurt, Main Hessia, Germany
Ruhrlandklinik Essen, Klinik fuer PneumologieRecruiting
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin Mainz - Zentrum für ThoraxerkrankungenRecruiting
Mainz, Rhineland-Palatinate, Germany
Uniklinikum Leipzig Medizinische Klinik II - BereichRecruiting
Leipzig, Saxony, Germany
Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und InfektiologieRecruiting
Berlin, State of Berlin, Germany
A.O.U. delle Marche - Ospedale di TorretteRecruiting
Torrette, Ancona, Italy
Azienda Ospedaliera dei Colli - Ospedale MonaldiRecruiting
Naples, Campania, Italy
Università degli Studi di Napoli Federico II - Ospedale MonaldiRecruiting
Naples, Campania, Italy
IRCCS AOU di Bologna - Policlinico Sant' OrsolaRecruiting
Bologna, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Giuliano IsontinaRecruiting
Venezia, Giulia, Italy
Fondazione IRCCS Policlinico San Matteo - UOC PneumologiaRecruiting
Pavia, Lombardy, Italy
Ospedale San GiuseppeRecruiting
Milan, Milano, Italy
HUMANITAS Research HospitalRecruiting
Rozzano, Milano, Italy
A.O.U. Policlinico G. RodolicoRecruiting
Catania, Sicily, Italy
St AntoniusziekenhuisRecruiting
Nieuwegein, Utrecht, Netherlands
Erasmus University Medical CenterRecruiting
Rotterdam, Netherlands
Greenlane Clinical CentreRecruiting
Auckland, Auckland, New Zealand
Health New ZealandRecruiting
Christchurch, Canterbury, New Zealand
Dunedin HospitalRecruiting
Dunedin, Dunedine, New Zealand
Bay of Plenty Clinical SchoolRecruiting
Tauranga, South Tauranga, New Zealand
Vitamed Galaj I Cichomski sp.j.Recruiting
Bydgoszcz, Bydgoszc, Poland
University Hospital in KrakowRecruiting
Krakow, Krakow, Poland
Department of Pneumology of the University Hospital No 1Recruiting
Lodz, Poland
PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek SuzinRecruiting
Lodz, Poland
AppleTreeClinics NetworkRecruiting
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Virgen de las NievesRecruiting
Granada, Andalusia, Spain
Hospital de Sant Pau y la Santa CreuRecruiting
Barcelona, Barcelona, Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Gregorio MarañonRecruiting
Madrid, Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Málaga, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Principality of Asturias, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Sevilla, Spain
Hospital Universitary de BellvitgeRecruiting
Barcelona, Spain
Hospital Universitario Puerta del Mar - Leon-JimenezRecruiting
Cadiz, Spain
Ege University Medical Faculty HospitalRecruiting
Bornova, İzmir, Turkey (Türkiye)
Cukurova University Medical FacultyRecruiting
Adana, Turkey (Türkiye)
Health Sciences University, Gulhane Faculty of MedicineRecruiting
Ankara, Turkey (Türkiye)
Hull University Teaching Hospital NHS TrustRecruiting
Cottingham, East Yorkshire, United Kingdom
Birmingham Heartlands HospitalRecruiting
Birmingham, Heartlands, United Kingdom
Leicester Biomedical Research Centre - Respiratory ThemeRecruiting
Glenfield, Leicester, United Kingdom
St George's University Hospitals NHS Foundation TrustRecruiting
London, London, United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust ThemeRecruiting
Birmingham, Midlands, United Kingdom
C-TRIC Altnagelvin HospitalRecruiting
Londonderry, Northern Ireland, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, Oxon, United Kingdom
Royal DevonRecruiting
Exeter, South West, United Kingdom
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and DevelopmentRecruiting
Wolverhampton, West Midlands, United Kingdom
St James University Hospital - LTHTRecruiting
Leeds, West Yorkshire, United Kingdom
Royal Papworth HospitalRecruiting
Cambridge, United Kingdom
Royal Brompton HospitalRecruiting
London, United Kingdom
Manchester University NHS Foundation TrustRecruiting
Manchester, United Kingdom
Nottingham University NHS TrustRecruiting
Nottingham, United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University HospitalRecruiting
Stoke-on-Trent, United Kingdom
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis · TrialPath