Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by S. Samuel Weigt, MD (ucla)
Headshot of S. Samuel Weigt
S. Samuel Weigt

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants with PPF

Details

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.

Keywords

Progressive Pulmonary Fibrosis, Chronic-Fibrosing-ILD with progressive phenotype, PF-ILD, Pulmonary Fibrosis, Fibrosis, Pirfenidone

Eligibility

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai accepting new patients
    Los Angeles California 90048 United States
  • Newport Native MD, Inc. accepting new patients
    Newport Beach California 92663 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • S. Samuel Weigt, MD (ucla)
    Clinical and translational research in lung transplantation and interstitial lung disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avalyn Pharma Inc.
Links
Content
ID
NCT06329401
Phase
Phase 2 Fibrosis Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated