Long-term safety study of inhaled AP01 for lung scarring diseases
Follows people with pulmonary fibrosis who previously took inhaled AP01 in earlier studies.
Plain-language title generated from the registry record
Registry title: An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Key facts
- Where
- Milan and Pavia, ItalySee the 3 sites
- Phase
- Phase 2
Where in Italy
- Humanitas Research HospitalMilan, ItalyTaking people
- Ospedale San Giuseppe/ MultiMedica SPAMilan, ItalyTaking people
- Fondazione IRCCS Policlinico San Matteo - UOC PneumologiaPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Avalyn Pharma Inc.
- Trial code
- NCT06951217
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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])
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.
Inclusion: 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.
Exclusion: 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).