NCT06329401

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Avalyn Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.

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
• Hypersensitivity Pneumonitis
• Interstitial Lung Disease With Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	AP01	Oral inhalation solution
OTHER	Placebo	Placebo oral inhalation solution

Timeline

• Start date: 2024-04-03
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-03-25
• Last updated: 2026-04-06

Locations

152 sites across 14 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, New Zealand, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study