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Taking people in FrancePhase 2

Long-term safety study of inhaled AP01 for lung scarring diseases

Follows people with pulmonary fibrosis who previously took inhaled AP01 in earlier studies.

Key facts

Who runs it
Avalyn Pharma Inc.
Where
Angers and Montrevel-en-Bresse, FranceSee the 2 sitesAlso in 12 other countries, 89 sites
Trial code
Registry title
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Status
Recruiting
Phase
Phase 2
People taking part
340 people, planned
Started
17 Apr 2025
Expected to end
31 Dec 2031
Type of study
Interventional
Treatments tested
  • AP01
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with progressive pulmonary fibrosis (or idiopathic pulmonary fibrosis outside the US and Canada) who finished an earlier Avalyn inhaled antifibrotic study on the full dose.

Age
18 years or older
Sex
All sexes can join
Disease stage
Progressive pulmonary fibrosis (PPF), or idiopathic pulmonary fibrosis (IPF) outside the US and Canada
Earlier treatment
Must have completed the final treatment visit of an Avalyn-sponsored inhaled antifibrotic study on the full dose of study drug (active or placebo), with the Study Physician's approval

Main reasons for not taking part

  • Did not take part in an Avalyn inhaled antifibrotic lead-in study, or was permanently stopped from it
  • Stopped the study drug but kept attending study visits in the lead-in study
  • Asthma or COPD flare needing steroids in the last 3 months
  • Sudden worsening of IPF or PPF in the last 3 months
  • Allergic reaction to pirfenidone or the study excipients

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician; Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo)
  • Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period

Who cannot take part

  • Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible
  • Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries
  • Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit)
  • History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study
  • Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit)

Where in France

Also in 12 other countries, 89 sites

  • Centre Hospitalier Universitaire D'AngersAngers, FranceContact: Frederic GagnadouxTaking people
  • University of MontpellierMontrevel-en-Bresse, FranceContact: Arnaud BourdinTaking people

About the trial

What the trial wants to find out

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

The group in the trial

  • Open-label AP01 treatment armTreatment being tested

    All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.

    Treatment: AP01

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])
Plain-language title
Long-term safety study of inhaled AP01 for lung scarring diseasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2026