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Clinical Trials in Canada / NCT06329401
Active, not recruiting Phase 2

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

NCT06329401 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-04-03
Last updated
2026-07-02

Condition(s) studied

Pulmonary FibrosisProgressive Pulmonary FibrosisPulmonary Fibrosis Secondary to Systemic SclerosisPulmonary Fibrosis, Interstitial Lung DiseaseInterstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease (Disorder)Interstitial Lung Disease in Patients With Rheumatoid ArthritisInterstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified ElsewhereHypersensitivity PneumonitisInterstitial Lung Disease With Systemic Sclerosis

Investigational drug(s) / intervention(s)

AP01 →Placebo

AP01: Oral inhalation solution

Placebo: Placebo oral inhalation solution

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (154)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Mayo Clinic- Scottsdale Scottsdale Arizona
University of Southern California Los Angeles California
Cedars-Sinai Los Angeles California
UCLA Los Angeles California
Newport Native MD, Inc. Newport Beach California
Paradigm Clinical Research - Redding Redding California
University of California - San Francisco San Francisco California
University of Colorado, Anschutz Medical Campus Aurora Colorado
National Jewish Health Denver Colorado
UCONN Health Farmington Connecticut
Yale University New Haven Connecticut
Clinical Site Partners, LCC Leesburg Florida
Renstar Medical Research Ocala Florida
Clinical Site Partners Winter Park Florida
Piedmont Healthcare, Inc. Atlanta Georgia
Northwestern University Chicago Illinois
Endeavor Health Evanston Illinois
Loyola University Medical Center Maywood Illinois
The University of Kansas Medical Center Kansas City Kansas
University of Maryland Baltimore Maryland
Johns Hopkins University Baltimore Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
University of Michigan Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
Hannibal Regional Healthcare System Hannibal Missouri
Northern Westchester Hospital Mount Kisco New York
Northwell Health - Mount Kisco Mount Kisco New York
NYU Langone Health New York New York
Weill Cornell New York New York
Icahn School of Medicine at Mount Sinai New York New York
Columbia University New York New York
Montefiore Medical Center The Bronx New York
Duke University Durham North Carolina
Piedmont HealthCare, PA Statesville North Carolina
Accellacare Wilmington North Carolina
Southeastern Research Center Winston-Salem North Carolina
University of Cincinnati Cincinnati Ohio
Cleveland Clinic Cleveland Ohio

+ 114 more sites — see the full list on the official registry below.

More Avalyn Pharma Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06329401 on ClinicalTrials.gov ↗ ← All trials in Canada