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

NCT06329401 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2026-04-06

No results posted yet for this 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.

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

DRUG

AP01

Oral inhalation solution

OTHER

Placebo

Placebo oral inhalation solution

Sponsors & Collaborators

  • DevPro Biopharma

    collaborator INDUSTRY

  • Avalyn Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Avalyn Pharma, Inc. · Avalyn Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329401 on ClinicalTrials.gov