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Recruiting Phase 2

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

NCT06951217 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-04-17
Last updated
2026-10-02

Condition(s) studied

Progressive Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)

Investigational drug(s) / intervention(s)

AP01

AP01: AP01 will be administered open-label via the eFlow Nebulizer System

Study 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 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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 (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.

Primary outcome measure(s)

  • To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01). — Through end of study; average of 6 years
    The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.

Trial sites (85)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of Southern California Los Angeles California Recruiting
Newport Native MD, Inc. Newport Beach California Recruiting
University of Colorado, Anschutz Medical Campus Aurora Colorado Recruiting
Yale University New Haven Connecticut Recruiting
Renstar Medical Research Ocala Florida Recruiting
Piedmont Healthcare, Inc. Atlanta Georgia Recruiting
The University of Kansas Medical Center Kansas City Kansas Recruiting
University of Maryland Baltimore Maryland Recruiting
Johns Hopkins Asthma and Allergy Center Baltimore Maryland Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Hannibal Regional Healthcare System, Inc. Hannibal Missouri Recruiting
Weill Cornell New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Columbia University New York New York Recruiting
Piedmont HealthCare, PA Statesville North Carolina Recruiting
Southeastern Research Center Winston-Salem North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Summit Health Bend Oregon Recruiting
The Oregon Clinic Pulmonary East Portland Oregon Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Temple University Hospital Philadelphia Pennsylvania Recruiting
Lowcountry Lung and Critical Care, PA Charleston South Carolina Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
El Paso Pulmonary Association, P.A. El Paso Texas Recruiting
Baylor College of Medicine Houston Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
University of Utah Salt Lake City Utah Recruiting
Inova Healthcare Falls Church Virginia Recruiting
University of Washington Seattle Washington Recruiting
CIMER Centro Integral de Medicina Respiratoria San Miguel de Tucumán Tucumán Province Recruiting
Investigaciones En Patologias Respiratorias San Miguel de Tucumán Tucumán Province Recruiting
Fundación Respirar Buenos Aires Argentina Recruiting
Clinica Monte Grande Buenos Aires Argentina Recruiting
Instituto Ave Pulmo, Fundacion Enfisema Buenos Aires Argentina Recruiting
Centro Respiratorio Quilmes Buenos Aires Argentina Recruiting
CINME Buenos Aires Argentina Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting

+ 45 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951217 on ClinicalTrials.gov ↗ ← All trials in the USA