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])
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of Southern California
RECRUITING
Los Angeles
Colorado
University of Colorado, Anschutz Medical Campus
RECRUITING
Aurora
Florida
Renstar Medical Research
RECRUITING
Ocala
Georgia
Piedmont Healthcare, Inc.
RECRUITING
Atlanta
Kansas
The University of Kansas Medical Center
RECRUITING
Kansas City
Maryland
Johns Hopkins Asthma and Allergy Center
RECRUITING
Baltimore
University of Maryland
RECRUITING
Baltimore
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Hannibal Regional Healthcare System, Inc.
RECRUITING
Hannibal
North Carolina
Piedmont HealthCare, PA
RECRUITING
Statesville
Southeastern Research Center
RECRUITING
Winston-salem
New York
Columbia University
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Oregon
Summit Health
RECRUITING
Bend
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
South Carolina
Lowcountry Lung and Critical Care, PA
RECRUITING
Charleston
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
El Paso Pulmonary Association, P.A.
RECRUITING
El Paso
Baylor College of Medicine
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah
RECRUITING
Salt Lake City
Virginia
Inova Healthcare
RECRUITING
Falls Church
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Argentina
Centro Respiratorio Quilmes
RECRUITING
Buenos Aires
CINME
RECRUITING
Buenos Aires
Clinica Monte Grande
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Instituto Ave Pulmo, Fundacion Enfisema
RECRUITING
Buenos Aires
Investigaciones En Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Prince Charles Hospital (TPCH)
RECRUITING
Chermside
Lung & Sleep Victoria
RECRUITING
Footscray
Respiratory Clinical Trials PTY Ltd
RECRUITING
Kent Town
Nepean Lung & Sleep
RECRUITING
Kingston
Macquarie University Clinical Trials Unit
RECRUITING
Macquarie Park
Univ of Western Australia / Institute for Respiratory Health
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
New Lambton Heights
Westmead Hospital
RECRUITING
Westmead
The Queen Elizabeth Hospital
ACTIVE_NOT_RECRUITING
Woodville South
Canada
Dynamic Drug Advancement
RECRUITING
Ajax
Research Institute McGill University Health Center
RECRUITING
Montreal
CIC Mauricie
RECRUITING
Trois-rivières
Centre for Lung Health
RECRUITING
Vancouver
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
University of Montpellier
RECRUITING
Montrevel-en-bresse
Germany
Studienzentrum Dr. Claus Keller
RECRUITING
Frankfurt
Medizinische Hochschule Hannover
RECRUITING
Hanover
Italy
HUMANITAS Research Hospital
RECRUITING
Milan
Ospedale San Giuseppe/ MultiMedica SPA
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
RECRUITING
Pavia
Netherlands
St Antonius Hospital
RECRUITING
Nieuwegein
New Zealand
Greenlane Clinical Centre
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Dunedin Hospital
ACTIVE_NOT_RECRUITING
Dunedin
Waikato Hospital
RECRUITING
Hamilton
Bay of Plenty Clinical Trials Unit
RECRUITING
Tauranga
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Department of Pneumology of the University Hospital No 1
RECRUITING
Lodz
Spain
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
RECRUITING
Birmingham
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Cambridge
Hull University Teaching Hospital
RECRUITING
Cottingham
Leicester Biomedical Research Centre
RECRUITING
Leicester
St. George's University Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Dr. Felix Woodhead, MB BChir,PhD
fwoodhead@avalynpharma.com
+44 7999 885973
Time Frame
Start Date: 2025-04-17
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 340
Treatments
Experimental: Open-label AP01 treatment arm
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.
Related Therapeutic Areas
Sponsors
Leads: Avalyn Pharma Inc.