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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06329401

Run by

Avalyn Pharma Inc.

People needed

375

Starts

2024-04-03

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
• 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.

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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