RECRUITING

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

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Conditions

Progressive Pulmonary FibrosisChronic-Fibrosing-ILD with progressive phenotype, PF-ILD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-03
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06329401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant meets criteria for PPF, as follows:
  2. * 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:
  3. 1. Relative decline in FVC ≥10% predicted within the previous 24 months compared to Screening Visit 1
  4. 2. Relative decline in FVC ≥5 to \<10% predicted within the previous 24 months compared to Screening Visit 1 with at least 1 of the 2 following criteria:
  5. * Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR
  6. * Radiological (HRCT) evidence of disease progression per a local or central radiologist, for example:
  7. * Increased extent or severity of traction bronchiectasis and bronchiolectasis
  8. * New ground-glass opacity with traction bronchiectasis
  9. * New fine reticulation
  10. * Increased extent or increased coarseness of reticular abnormality
  11. * New or increased honeycombing
  12. * Increased lobar volume loss
  13. 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
  14. * Meeting all of the following criteria during the Screening Period:
  1. * Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months prior to Screening.
  2. * Elevated liver enzymes and liver injury at Screening defined as:
  3. 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
  4. 2. Bilirubin \>2.0 x ULN
  5. * Renal disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.
  6. * 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.
  7. * Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
  8. * Significant clinical worsening of PPF between Screening
  9. * 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.

Contacts and Locations

Study Contact

Craig S. Conoscenti, MD
CONTACT
206-707-0304
cconoscenti@avalynpharma.com
Daniele Tompkins
CONTACT
973-983-3700
dtompkins@devprobiopharma.com

Principal Investigator

Avalyn Pharma, Inc.
STUDY_DIRECTOR
Avalyn Pharma Inc.

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Pulmonary Associates, PA
Phoenix, Arizona, 85032
United States
University of Southern California
Los Angeles, California, 90033
United States
UCLA
Los Angeles, California, 90095
United States
Newport Native MD, Inc.
Newport Beach, California, 92663
United States
Paradigm Clinical Research - Redding
Redding, California, 96001
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
United States
National Jewish Health
Denver, Colorado, 80206
United States
UCONN Health
Farmington, Connecticut, 06030
United States
Clinical Site Partners, LCC
Leesburg, Florida, 34748
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Central Florida Pulmonary Group
Orlando, Florida, 32803
United States
SEC Clinical Research
Pensacola, Florida, 32503
United States
Clinical Site Partners
Winter Park, Florida, 32789
United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309
United States
Northwestern University
Chicago, Illinois, 60611
United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Johns Hopkins University
Baltimore, Maryland, 21224
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Hannibal Regional Healthcare System
Hannibal, Missouri, 63401
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Northwell Health - Mount Kisco
Mount Kisco, New York, 10549
United States
NYU Langone Health
New York, New York, 10017
United States
Weill Cornell
New York, New York, 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Duke University
Durham, North Carolina, 27710
United States
Pulmonix
Greensboro, North Carolina, 27403
United States
Piedmont HealthCare, PA
Statesville, North Carolina, 28625
United States
Accellacare
Wilmington, North Carolina, 28401
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
The Oregon Clinic Pulmonary East
Portland, Oregon, 97220
United States
The Oregon Clinic Pulmonary West
Portland, Oregon, 97225
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
United States
Vanderbilt Lung Institute
Nashville, Tennessee, 37204
United States
El Paso Pulmonary Association
El Paso, Texas, 79902
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas, 75069
United States
Intermountain Medical Center
Murray, Utah, 84157
United States
Inova Healthcare
Falls Church, Virginia, 22042
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Avalyn Pharma Inc.

  • Avalyn Pharma, Inc., STUDY_DIRECTOR, Avalyn Pharma Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Chronic-Fibrosing-ILD with progressive phenotype, PF-ILD

Additional Relevant MeSH Terms

  • Progressive Pulmonary Fibrosis