SAIL - Open-Label Extension Study of Participants who Received an Avalyn Inhaled Antifibrotic Agent
Research type
Research Study
Full title
A Multinational, Long-Term, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])
IRAS ID
1011102
Contact name
Felix Woodhead
Contact email
Sponsor organisation
Avalyn Pharma Inc.
Research summary
Avalyn is studying an investigational drug called AP01 as a possible treatment for progressive, fibrosing interstitial lung disease (ILD). The active component of AP01 (pirfenidone) is approved as treatment for certain types of ILD when it is given as a capsule for oral use, but in this study, it is investigational because it will be administered to participants by inhalation using a nebuliser device. A nebuliser device converts liquid drug into a mist for participants to breathe into their lungs.
The main purpose of this study is to allow participants who have a progressing, fibrosing ILD and who have taken part in a previous Avalyn Pharma Inc. (Avalyn) study of AP01 to continue taking AP01 for as long as the participants can tolerate treatment, until it is approved for use in the UK, or until the study is stopped. The safety of the study drug and how well it is working will also be monitored.
The study visits will be a continuation from the lead-in study, with the first study visit of this extension study being on the same day as the last study visit of the lead-in study.
The study will consist of a Screening/Baseline Visit (Day 1), a Treatment Period, and a Follow-up/End of Study (EOS) phone call. Participants will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug.
Up to approximately 340 subjects may be enrolled but is dependent on the number of participants who choose to roll over from each lead-in study and are eligible for this extension study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0009
Date of REC Opinion
16 Apr 2025
REC opinion
Further Information Favourable Opinion