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AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Sponsor: Avalyn Pharma Inc.
Summary
This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability. Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months. Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation. Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-03-10
Completion Date
2027-06
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
AP02
Oral inhalation solution
Placebo
Placebo oral inhalation solution
Locations (24)
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Lung and Sleep
Kingswood, New South Wales, Australia
Ludwig Engel Centre for Respiratory Research
Westmead, New South Wales, Australia
Centre for Lung Health - Vancouver General Hospital
Vancouver, British Columbia, Canada
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth
Halifax, Nova Scotia, Canada
Dynamic Drug Advancement
Ajax, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
CIC Mauricie
Trois-Rivières, Quebec, Canada
Pneumologisches Studienzentrum München-West
Munich, Bavaria, Germany
Studienzentrum Dr. Keller
Frankfurt am Main, Hesse, Germany
Christchurch Hospital
Christchurch, Cantebury, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Greenlane Clinical Centre
Auckland, New Zealand
Hospital Germans Trias i Pujol/Hospital Can Ruti
Badalona, Barcelona, Spain
Hospital General de Granollers, Barcelona
Granollers, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital HM Sanchinarro
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Royal Devon University Hospital
Exeter, Devon, United Kingdom
Hull University Hospitals NHS Trust
Cottingham, East Riding of Yorkshire, United Kingdom
Leicester Biomedical Research Centre
Leicester, Leicestershire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom