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NCT06329401 · ClinicalTrials.gov record · last posted 2026-07-02

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

StatusActive, Not Recruiting
PhasePhase 2
Started2024-04-03
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-06-19
Trial status changed: Recruiting → Active, Not Recruiting
Trial Details
NCT Number NCT06329401
Lead Sponsor Avalyn Pharma Inc.
Collaborators: DevPro Biopharma
Conditions 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 +2 more
Enrollment 375 participants
Start Date 2024-04-03
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-02