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

RecruitingPhase 2

A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Avalyn Pharma Inc. · Participants: 340 · Started: Apr 17, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06951217

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
CaliforniaUniversity of Southern California, Los Angeles
ColoradoUniversity of Colorado, Anschutz Medical Campus, Aurora
FloridaRenstar Medical Research, Ocala
GeorgiaPiedmont Healthcare, Inc., Atlanta
KansasThe University of Kansas Medical Center, Kansas City
MarylandJohns Hopkins Asthma and Allergy Center, Baltimore
University of Maryland, Baltimore
MinnesotaMayo Clinic Rochester, Rochester
MissouriHannibal Regional Healthcare System, Inc., Hannibal
New YorkColumbia University, New York
Icahn School of Medicine at Mount Sinai, New York
North CarolinaPiedmont HealthCare, PA, Statesville
Southeastern Research Center, Winston-Salem
OhioUniversity of Cincinnati, Cincinnati
OregonSummit Health, Bend
PennsylvaniaTemple University Hospital, Philadelphia
Thomas Jefferson University, Philadelphia
South CarolinaLowcountry Lung and Critical Care, PA, Charleston
Medical University of South Carolina, Charleston
TennesseeVanderbilt University Medical Center, Nashville
TexasEl Paso Pulmonary Association, P.A., El Paso
Baylor College of Medicine, Houston
UtahIntermountain Medical Center, Murray
University of Utah, Salt Lake City
VirginiaInova Healthcare, Falls Church
WashingtonUniversity of Washington, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.