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RecruitingPhase 2

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

Avalyn Pharma Inc. · NCT06951217

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
340
US sites recruiting
31
Study start
April 17, 2025
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AP01

Conditions: Progressive Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35205

    Site contact: Tejaswini Kulkarni · tanzira.zaman@cshs.org

  • University of Southern California

    Los Angeles, CA 90033

    Site contact: Toby Maher · toby.maher@med.usc.edu

  • Newport Native MD, Inc.

    Newport Beach, CA 92663

    Site contact: Ryan Klein · ryan@newportnativemd.com

  • University of Colorado, Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Joyce Lee · joyce.lee@cuanschutz.edu

  • Yale University

    New Haven, CT 06519

    Site contact: Mridu Gulati · mridu.gulati@yale.edu

  • Renstar Medical Research

    Ocala, FL 34470

    Site contact: Raj Karunakara · raj.karunakara@renstar.net

  • Piedmont Healthcare, Inc.

    Atlanta, GA 30309

    Site contact: Amy Case · amy.case@piedmont.org

  • The University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Mark Hamblin · mhamblin@kumc.edu

  • University of Maryland

    Baltimore, MD 21201

    Site contact: ebritt@som.umaryland.edu

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, MD 21205

    Site contact: mlammi2@jh.edu

  • Mayo Clinic Rochester

    Rochester, MN 55905

    Site contact: Andrew Limper · limper.andrew@mayo.edu

  • Hannibal Regional Healthcare System, Inc.

    Hannibal, MO 63401

    Site contact: Humam Farah · humam.farah@hannibalclinic.com

  • Weill Cornell

    New York, NY 10021

    Site contact: Anna Podolanczuk · ajp9012@med.cornell.edu

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Maria Padilla · maria.padilla@mountsinai.org

  • Columbia University

    New York, NY 10032

    Site contact: Claire McGroder · cm3485@cumc.columbia.edu

  • Piedmont HealthCare, PA

    Statesville, NC 28625

    Site contact: Jose Perez · jose.perez@piedmonthealthcare.com

  • Southeastern Research Center

    Winston-Salem, NC 27103

    Site contact: Jason Thomason · jthomason@southeasternresearchcenter.com

  • University of Cincinnati

    Cincinnati, OH 45267

    Site contact: Nishant Gupta · guptans@ucmail.us.edu

  • Summit Health

    Bend, OR 97701

    Site contact: Jeremy Feldman · jfeldman@summithealth.com

  • The Oregon Clinic Pulmonary East

    Portland, OR 97220

    Site contact: David Hotchkin · dhotchkin@orclinic.com

  • Thomas Jefferson University

    Philadelphia, PA 19107

    Site contact: Ross Summer · ross.summer@jefferson.edu

  • Temple University Hospital

    Philadelphia, PA 19140

    Site contact: Gerard Criner · gerard.criner@tuhs.temple.edu

  • Lowcountry Lung and Critical Care, PA

    Charleston, SC 29406

    Site contact: Thomas Kaelin, Jr · tkaelin@lowcountrylung.com

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Timothy Whelan · whelant@musc.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37204

    Site contact: Justin Hewlett, MD · justin.c.hewlett@vumc.org

  • El Paso Pulmonary Association, P.A.

    El Paso, TX 79902

    Site contact: Carlo Hatem, MD · carlo.hatem@elligodirect.com

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Ivan Rosas · ivan.rosas@bcm.edu

  • Intermountain Medical Center

    Murray, UT 84107

    Site contact: Peter Crossno · peter.crossno@imail.org

  • University of Utah

    Salt Lake City, UT 84108

    Site contact: mary.beth.scholand@hsc.utah.edu

  • Inova Healthcare

    Falls Church, VA 22042

    Site contact: vikramjit.khangoora@inova.org

  • University of Washington

    Seattle, WA 98195

    Site contact: Suha Kadura · skadura@uw.edu

Study contacts (from the official record)

  • Dr. Felix Woodhead, MB BChir,PhD · +44 7999 885973 · fwoodhead@avalynpharma.com
An Extension Study of Subjects Who Received an Avalyn Inhaled… (NCT06951217) | Bored Studies