Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Idiopathic Pulmonary Fibrosis (IPF)
Led by Avalyn Pharma Inc. · Updated on 2026-04-06
160
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Nintedanib Solution for Inhalation (AP02) in adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF). The study aims to assess the impact of AP02 on lung function and key fibrosis measures, as well as its safety and tolerability. Participants must meet specific criteria including not currently being treated for IPF or having stopped oral nintedanib or pirfenidone at least 3 months prior. Participants are randomly assigned to one of three groups: two different doses of AP02 or a placebo. The study treatment is given by inhalation using a nebulizer twice daily for 12 weeks. The trial includes six office visits and one phone call over a 16-week period to monitor treatment effects and participant health. During study visits, doctors perform breathing tests to measure lung function, give questionnaires, and check participants' health. The main outcome measured is the change in forced vital capacity (FVC) after 12 weeks of treatment. Researchers also evaluate disease progression and changes in lung fibrosis using imaging scores. Safety and tolerability are continuously assessed throughout the study period.
CONDITIONS
Brief 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 at the time of signing the written informed consent form
- Diagnosis of idiopathic pulmonary fibrosis (IPF) within 5 years according to specific guidelines
- High-Resolution CT pattern and, if available, surgical lung biopsy consistent with IPF diagnosis
- Stable condition suitable for study participation based on medical history, physical exam, vital signs, ECG, and labs
- Forced vital capacity (FVC) 60 45% of predicted normal
- Lung diffusion capacity (DLCO) corrected for hemoglobin between 30% and 80% of predicted normal
- Women and men of childbearing potential must use highly effective contraception until 90 days after last dose
You will not qualify if you...
- Current treatment with oral nintedanib or pirfenidone, or treatment within 3 months prior to screening
- Previous combined treatment with both oral nintedanib and pirfenidone
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio 60.7 (pre-bronchodilator)
- History of serious cardiovascular disease, bleeding problems, or significant liver or kidney disease
- History of diverticular disease or abdominal surgery within 4 weeks before screening
- History of cancer in past 5 years (except certain types)
- Smoking within 3 months before screening or unwillingness to stop smoking during study
- Current use of illegal drugs or drugs of abuse
- Pregnant or nursing women
- Use of any investigational drugs within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive inhaled study medication (AP02 or placebo) twice daily to evaluate safety and efficacy in idiopathic pulmonary fibrosis.
1 baseline visit and multiple follow-up visits during treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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