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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 (43) 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
Colorado
University of Colorado, Anschutz Medical Campus
RECRUITING
Aurora
Florida
Renstar Medical Research
RECRUITING
Ocala
Georgia
Piedmont Healthcare, Inc.
RECRUITING
Atlanta
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
The University of Kansas Medical Center
RECRUITING
Kansas
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
Utah
Intermountain Medical Center
RECRUITING
Murray
Other Locations
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
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
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
Italy
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
RECRUITING
Pavia
Netherlands
St Antonius Hospital
RECRUITING
Nieuwegein
New Zealand
Greenlane Clinical Centre
RECRUITING
Auckland
Dunedin Hospital
ACTIVE_NOT_RECRUITING
Dunedin
Waikato Hospital
RECRUITING
Hamilton
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Department of Pneumology of the University Hospital No 1
RECRUITING
Lodz
Spain
Hospital Gregorio Marañon
RECRUITING
Madrid
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Cambridge
Leicester Biomedical Research Centre
RECRUITING
Leicester
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.