Actively Recruiting
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Led by Avalyn Pharma Inc. · Updated on 2026-04-06
160
Participants Needed
3
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 60 years or older at the time of signing the informed consent form
- Diagnosis of idiopathic pulmonary fibrosis (IPF) within the last 5 years based on official guidelines
- Combination of High-Resolution CT scan pattern and, if available, lung biopsy consistent with IPF diagnosis
- Stable condition suitable for study participation based on medical history, physical exam, vital signs, ECG, and lab tests
- Forced vital capacity (FVC) at least 45% of predicted normal
- Lung diffusion test (DLCO) corrected for hemoglobin at least 30% and up to 80% predicted normal
- Women and men of childbearing potential must use highly effective contraception until 90 days after last study drug dose
You will not qualify if you...
- Current or recent (within 3 months) treatment with oral nintedanib or pirfenidone; prior combined use of both drugs
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio less than or equal to 0.7 before bronchodilator
- History of serious cardiovascular disease, bleeding problems, or significant liver or kidney disease
- Diverticular disease or abdominal surgery within 4 weeks prior to screening
- History of cancer within the past 5 years (except certain types as explained in protocol)
- Smoking within the past 3 months, unwillingness to stop smoking during the study, or current use of illegal drugs
- Pregnant or nursing female participants
- Use of any investigational drugs within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Nepean Lung and Sleep
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
Dynamic Drug Advancement
Ajax, Ontario, Canada, L1S2J5
Actively Recruiting
3
CIC Mauricie
Trois-Rivières, Quebec, Canada, G8T 7A1
Active, Not Recruiting
Research Team
C
Craig S Conoscenti, MD, FCCP, ATSF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here