Status:
RECRUITING
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Lead Sponsor:
Avalyn Pharma Inc.
Conditions:
Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
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.
- 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 (IPF subjects are excluded from the US and Canada) 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.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06951217
Start Date
April 17 2025
End Date
December 31 2031
Last Update
December 16 2025
Active Locations (23)
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1
Renstar Medical Research
Ocala, Florida, United States, 34470
2
Columbia University
New York, New York, United States, 10032
3
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
4
University of Cincinnati
Cincinnati, Ohio, United States, 45267