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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

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.

Key facts

Study ID: NCT07194382
Run by: Avalyn Pharma Inc.
People needed: 160
Starts: 2026-03-10
Expected to finish: 2027-06-01
Last updated by the study team: 2026-08-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female patients aged ≥40 years at the time of signing the written informed consent form
Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years
Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF
In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
Forced vital capacity (FVC) ≥45% predicted of normal
Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal.
Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug.

You may not qualify if…

Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study.
Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value
Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol)
History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit
History of cancer within the past 5 years (except for certain types explained in the protocol)
Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse
Female participants who are pregnant or nursing
Use of any investigational drugs including those for IPF within the past 30 days prior to screening
Further inclusion/exclusion criteria apply

Where it is running

Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
Nepean Lung and Sleep — Kingswood, New South Wales, Australia (enrolling)
Ludwig Engel Centre for Respiratory Research — Westmead, New South Wales, Australia (enrolling)
Centre for Lung Health - Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
Newfoundland and Labrador Health Services — St. John's, Newfoundland and Labrador, Canada (enrolling)
Queen Elizabeth — Halifax, Nova Scotia, Canada (enrolling)
Dynamic Drug Advancement — Ajax, Ontario, Canada (enrolling)
Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (enrolling)
CIC Mauricie — Trois-Rivières, Quebec, Canada (enrolling)
Pneumologisches Studienzentrum München-West — Munich, Bavaria, Germany (enrolling)
Studienzentrum Dr. Keller — Frankfurt am Main, Hesse, Germany (enrolling)
Christchurch Hospital — Christchurch, Cantebury, New Zealand (enrolling)
Waikato Hospital — Hamilton, Waikato Region, New Zealand (enrolling)
Greenlane Clinical Centre — Auckland, New Zealand (enrolling)
Hospital Germans Trias i Pujol/Hospital Can Ruti — Badalona, Barcelona, Spain (enrolling)
Hospital General de Granollers, Barcelona — Granollers, Barcelona, Spain (enrolling)
Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (enrolling)
Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)
Hospital HM Sanchinarro — Madrid, Spain (enrolling)
Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
Royal Devon University Hospital — Exeter, Devon, United Kingdom (enrolling)
Hull University Hospitals NHS Trust — Cottingham, East Riding of Yorkshire, United Kingdom (enrolling)
Leicester Biomedical Research Centre — Leicester, Leicestershire, United Kingdom (enrolling)
University Hospitals Birmingham NHS Foundation Trust — Birmingham, West Midlands, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.