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

NCT06951217 | Recruiting Phase 2 FDA Drug FDA Device

• 2 other identifiers: AP-LTE-008ACTRN12625000246482
• Study Type: interventional
• Target: 340
• Locations: 12 countries
• Sites: 52

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 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.

Conditions

Progressive Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).

  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.

  Through end of study; average of 6 years

Secondary Outcomes (3)

• To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated.

  Through end of study; average of 6 years

• To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease.

  Through end of study; average of 6 years

• To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL).

  Through end of study; average of 6 years

Study Arms (1)

Open-label AP01 treatment arm

EXPERIMENTAL

All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.

Combination Product: AP01

Interventions

AP01 COMBINATION_PRODUCT

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

Open-label AP01 treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avalyn Pharma Inc.: lead

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

Piedmont Healthcare, Inc.

Atlanta, Georgia, 30309, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55901, United States

RECRUITING

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri, 63401, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Piedmont HealthCare, PA

Statesville, North Carolina, 28625, United States

RECRUITING

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

The University of Kansas Medical Center

Kansas, Ohio, 66160, United States

RECRUITING

Summit Health

Bend, Oregon, 97701, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, 29406, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

RECRUITING

El Paso Pulmonary Association, P.A.

El Paso, Texas, 79902, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Inova Healthcare

Falls Church, Virginia, 22042, United States

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

ACTIVE NOT RECRUITING

Royal Prince Alfred Hospital

Camperdown, Australia

RECRUITING

The Prince Charles Hospital (TPCH)

Chermside, Australia

RECRUITING

Lung & Sleep Victoria

Footscray, Australia

RECRUITING

Respiratory Clinical Trials PTY Ltd

Kent Town, Australia

RECRUITING

Nepean Lung & Sleep

Kingston, Australia

RECRUITING

Univ of Western Australia / Institute for Respiratory Health

Nedlands, Australia

RECRUITING

John Hunter Hospital

New Lambton Heights, Australia

RECRUITING

Dynamic Drug Advancement

Ajax, Ontario, Canada

RECRUITING

Research Institute McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

CIC Mauricie

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

Centre for Lung Health

Vancouver, V5Z1M9, Canada

RECRUITING

Fakultni Thomayerove nemocnice

Praha Klanovice, Czechia

RECRUITING

University of Montpellier

Montrevel-en-Bresse, Montpellier, 34090, France

RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

RECRUITING

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

Pavia, Lombardy, 27100, Italy

RECRUITING

St Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Greenlane Clinical Centre

Auckland, New Zealand

RECRUITING

Dunedin Hospital

Dunedin, 9016, New Zealand

ACTIVE NOT RECRUITING

Waikato Hospital

Hamilton, New Zealand

RECRUITING

Bay of Plenty Clinical Trials Unit

Tauranga, 3112, New Zealand

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80211, Poland

RECRUITING

Department of Pneumology of the University Hospital No 1

Lodz, 90315, Poland

RECRUITING

Hospital Gregorio Marañon

Madrid, Spain

RECRUITING

Hull University Teaching Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

RECRUITING

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY, United Kingdom

RECRUITING

Leicester Biomedical Research Centre

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Avalyn Pharma, Inc.

  Avalyn Pharma Inc.

  STUDY DIRECTOR

Central Study Contacts

Dr. Felix Woodhead, MB BChir,PhD

CONTACT

+44 7999 885973; fwoodhead@avalynpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 30, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9); ES (1); FR (2); DE (1); CA (4); CZ (1); IT (1); PL (2); NZ (4); US (23); GB (3); NL (1)