An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Launched by AVALYN PHARMA INC. · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial, called the SAIL study, is looking at the long-term effects of an inhaled medication called pirfenidone (AP01) in patients with progressive pulmonary fibrosis, including a specific type known as idiopathic pulmonary fibrosis (IPF). If you previously participated in an Avalyn-sponsored study and completed the treatment, you may be eligible to join this extension study. In this trial, all participants will take 100 mg of the inhaled medication twice daily using a special nebulizer, which is a device that turns liquid medicine into a mist for easy breathing.

To ensure everyone knows how to use the nebulizer properly, new participants will receive hands-on training during their first visit, and they’ll also use a paper diary to keep track of their medication use. It’s important to note that only those who have successfully completed the earlier study and meet specific health criteria can join this trial. If you have questions about your eligibility or the study itself, feel free to ask your healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) 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 Criteria:
• • 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.
• • 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).
• • Subjects who experienced an acute exacerbation of IPF or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
• • 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.
• • History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.