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

Status: Recruiting
Location: See all (135) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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):

⁃ Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments

⁃ 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

⁃ 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Pulmonary Associates, PA
RECRUITING
Phoenix
California
Cedars-Sinai
RECRUITING
Los Angeles
UCLA
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Newport Native MD, Inc.
RECRUITING
Newport Beach
Paradigm Clinical Research - Redding
RECRUITING
Redding
Colorado
University of Colorado, Anschutz Medical Campus
RECRUITING
Aurora
National Jewish Health
RECRUITING
Denver
Connecticut
UCONN Health
RECRUITING
Farmington
Yale University
RECRUITING
New Haven
Florida
Clinical Site Partners, LCC
RECRUITING
Leesburg
Renstar Medical Research
RECRUITING
Ocala
Central Florida Pulmonary Group
RECRUITING
Orlando
SEC Clinical Research
RECRUITING
Pensacola
Clinical Site Partners
RECRUITING
Winter Park
Georgia
Piedmont Healthcare, Inc.
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Endeavor Health
RECRUITING
Evanston
Loyola University Medical Center
RECRUITING
Maywood
Kansas
The University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
University of Maryland
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Hannibal Regional Healthcare System
RECRUITING
Hannibal
North Carolina
Duke University
RECRUITING
Durham
Pulmonix
RECRUITING
Greensboro
Piedmont HealthCare, PA
RECRUITING
Statesville
Accellacare
RECRUITING
Wilmington
Southeastern Research Center
RECRUITING
Winston-salem
New York
Northwell Health - Mount Kisco
RECRUITING
Mount Kisco
Columbia University
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Weill Cornell
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Oregon
Summit Health
RECRUITING
Bend
The Oregon Clinic Pulmonary East
RECRUITING
Portland
The Oregon Clinic Pulmonary West
RECRUITING
Portland
Pennsylvania
The Pennsylvania State University
RECRUITING
Hershey
Temple University
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
South Carolina
Lowcountry Lung and Critical Care
RECRUITING
Charleston
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Clinical Trials Center of Middle Tennessee
RECRUITING
Franklin
Vanderbilt Lung Institute
RECRUITING
Nashville
Texas
Baylor Scott & White Research Institute, Baylor University Medical Center
RECRUITING
Dallas
El Paso Pulmonary Association
RECRUITING
El Paso
Baylor College of Medicine
RECRUITING
Houston
The University of Texas Health Science Center
RECRUITING
Houston
Metroplex Pulmonary and Sleep Center, PA
RECRUITING
Mckinney
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah Health
RECRUITING
Salt Lake City
Virginia
Inova Healthcare
RECRUITING
Falls Church
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Argentina
CINME
RECRUITING
Buenos Aires
Fundacion Respirar
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto de Medicina Respiratoria
RECRUITING
Córdoba
Instituto Ave Pulmo, Fundacion Enfisema
RECRUITING
Mar Del Plata
Centro Respiratorio Quilmes
RECRUITING
Quilmes
CIMER Centro Integral de Medicina Respiratoria
RECRUITING
San Miguel De Tucumán
Investigaciones En Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Australia
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
RECRUITING
Brisbane
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Canberra Hospital
RECRUITING
Canberra
Lung Research Victoria
RECRUITING
Footscray
Nepean Lung & Sleep
RECRUITING
Kingswood
Alfred Health
RECRUITING
Melbourne
Institute for Respiratory Health
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
New Lambton
Macquarie University Clinical Trials Unit
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Westmead
Canada
Dynamic Drug Advancement
RECRUITING
Ajax
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Research Institute McGill University Health Center
RECRUITING
Montreal
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
RECRUITING
Québec
CIC Mauricie
RECRUITING
Trois-rivières
Vancouver General Hospital
RECRUITING
Vancouver
France
CHU Angers
RECRUITING
Angers
APHP - Hopital Bicetre
RECRUITING
Le Kremlin-bicêtre
Louis Pradel Hospital
RECRUITING
Lyon
Robert Schuman Hospital UNEOS
RECRUITING
Metz
University of Montpellier
RECRUITING
Montpellier
Hôpital Haut-Lévêque
RECRUITING
Pessac
CHU de Rennes
RECRUITING
Rennes
CHU Tours
RECRUITING
Tours
Germany
Ruhrlandklinik Essen, Klinik fuer Pneumologie
RECRUITING
Essen
Studienzentrum Dr. Claus Keller
RECRUITING
Frankfurt
Medizinische Hochschule Hannover
RECRUITING
Hanover
Uniklinikum Leipzig Medizinische Klinik II - Bereich
RECRUITING
Leipzig
Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
RECRUITING
Mainz
Pneumologisches Studienzentrum München-West
RECRUITING
Munich
RoMed Klinikum Rosenheim
RECRUITING
Rosenheim
Italy
IRCCS AOU di Bologna - Policlinico Sant' Orsola
RECRUITING
Bologna
A.O.U. Policlinico G. Rodolico
RECRUITING
Catania
Ospedale San Giuseppe
RECRUITING
Milan
Azienda Ospedaliera dei Colli - Ospedale Monaldi
RECRUITING
Naples
Università degli Studi di Napoli Federico II - Ospedale Monaldi
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
RECRUITING
Pavia
HUMANITAS Research Hospital
RECRUITING
Rozzano
A.O.U. delle Marche - Ospedale di Torrette
RECRUITING
Torrette
Azienda Sanitaria Universitaria Giuliano Isontina
RECRUITING
Venezia
New Zealand
Greenlane Clinical Centre
RECRUITING
Auckland
Health New Zealand
RECRUITING
Christchurch
Dunedin Hospital
RECRUITING
Dunedin
Bay of Plenty Clinical School
RECRUITING
Tauranga
Poland
Vitamed Galaj I Cichomski sp.j.
RECRUITING
Bydgoszcz
AppleTreeClinics Network
RECRUITING
Lodz
PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
RECRUITING
Lodz
Spain
Hospital de Sant Pau y la Santa Creu
RECRUITING
Barcelona
Hospital Universitary de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Puerta del Mar - Leon-Jimenez
RECRUITING
Cadiz
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Turkey
Cukurova University Medical Faculty
RECRUITING
Adana
Health Sciences University, Gulhane Faculty of Medicine
RECRUITING
Ankara
Ege University Medical Faculty Hospital
RECRUITING
Bornova
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
RECRUITING
Birmingham
Hull University Teaching Hospital NHS Trust
RECRUITING
Cottingham
Royal Devon
RECRUITING
Exeter
Leicester Biomedical Research Centre - Respiratory Theme
RECRUITING
Glenfield
St James University Hospital - LTHT
RECRUITING
Leeds
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
RECRUITING
Wolverhampton
Contact Information
Primary
Craig S. Conoscenti, MD
cconoscenti@avalynpharma.com
206-707-0304
Backup
Daniele Tompkins
dtompkins@devprobiopharma.com
973-983-3700
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2026-04
Participants
Target number of participants: 300
Treatments
Experimental: AP01 High Dose BID
Pirfenidone Solution for Inhalation
Experimental: AP01 Low Dose BID
Pirfenidone Solution for Inhalation
Placebo_comparator: Placebo BID
Placebo solution for inhalation
Related Therapeutic Areas
Sponsors
Leads: Avalyn Pharma Inc.
Collaborators: DevPro Biopharma

This content was sourced from clinicaltrials.gov

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