ClinicaliQ Trial Snapshot
- An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL) — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT06951217.
- What is being tested: Long-term safety and efficacy outcomes of Avalyn's inhaled antifibrotic agent (AP01) in participants who previously completed earlier phase trials, using an open-label extension design to gather extended follow-up data.
- Patient eligibility overview: Prior participants from Avalyn-sponsored antifibrotic studies who successfully completed their initial trial protocols and met continuation criteria are eligible for enrolment into this extension phase.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.