← Eichor
Study identifier: NCT07194382 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF

Condition: Idiopathic Pulmonary Fibrosis (IPF)  ·  Sponsor: Avalyn Pharma Inc.

PhasePhase 2
Planned participants160
Who can joinAll sexes, 40 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Craig S Conoscenti, MD, FCCP, ATSF  ·  206-707-0340  ·  AP02-003regulatory@avalynpharma.com

Always discuss trial participation with your own doctor first.

Locations (3)

Nepean Lung and SleepKingswood, New South Wales, AustraliaRecruiting
Dynamic Drug AdvancementAjax, Ontario, CanadaRecruiting
CIC MauricieTrois-Rivières, Quebec, CanadaActive Not Recruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT07194382