AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF (NCT07194382)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Royal Prince Alfred Hospital — Camperdown, New South Wales
Age range: 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Nepean Lung and Sleep — Kingswood, New South Wales
- Ludwig Engel Centre for Respiratory Research — Westmead, New South Wales
- Centre for Lung Health - Vancouver General Hospital — Vancouver, British Columbia
- Newfoundland and Labrador Health Services — St. John's, Newfoundland and Labrador
- Queen Elizabeth — Halifax, Nova Scotia
- Dynamic Drug Advancement — Ajax, Ontario
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec
- CIC Mauricie — Trois-Rivières, Quebec
- Pneumologisches Studienzentrum München-West — Munich, Bavaria
- Studienzentrum Dr. Keller — Frankfurt am Main, Hesse
- Christchurch Hospital — Christchurch, Cantebury
- Waikato Hospital — Hamilton, Waikato Region
- Greenlane Clinical Centre — Auckland,
- Hospital Germans Trias i Pujol/Hospital Can Ruti — Badalona, Barcelona
- Hospital General de Granollers, Barcelona — Granollers, Barcelona
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria
- Hospital Clínic de Barcelona — Barcelona,
- Hospital HM Sanchinarro — Madrid,
- Hospital Universitario Virgen de la Victoria — Málaga,
- Royal Devon University Hospital — Exeter, Devon
- Hull University Hospitals NHS Trust — Cottingham, East Riding of Yorkshire
- Leicester Biomedical Research Centre — Leicester, Leicestershire
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, West Midlands
📞 Contact the Study Coordinator
Phone: (206) 707-0340
Email: AP02-003regulatory@avalynpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Pulmonary Fibrosis (IPF)
- A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. — Birmingham, Alabama
- Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis — Denver, Colorado
- A Comparison of a Medication Adherence Platform (FORTISKAP™) vs. Usual Care in Subjects on Oral Medications for the Treatment of Interstitial Lung Disease, Sarcoid and Pulmonary Hypertension — Norfolk, Virginia
- Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) — Palm Spring, California
- The Genetics of Pulmonary Fibrosis — Aurora, Colorado
- Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis — Birmingham, Alabama
Explore by condition: All Idiopathic Pulmonary Fibrosis (IPF) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.