AP02 for Idiopathic Pulmonary Fibrosis
(AURA-IPF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhalation solution, AP02, to determine its effectiveness in improving lung function in individuals with idiopathic pulmonary fibrosis (IPF), a condition that causes lung scarring. Researchers aim to assess whether AP02 is safe, well-tolerated, and effective compared to a placebo (a look-alike substance containing no drug). Participants will be divided into three groups to receive either a low dose, high dose of AP02, or a placebo, administered twice daily for 12 weeks using a nebulizer (a device that turns liquid medicine into mist). Adults diagnosed with IPF in the past five years who are not currently on treatment for IPF, or who stopped treatment with specific medications (nintedanib or pirfenidone) at least three months ago, may be eligible to join. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in IPF treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AP02, an inhaled version of the drug nintedanib, was well-tolerated in past studies. In one study, participants did not experience any serious side effects when taking single doses up to 2mg, suggesting that the inhaled treatment is generally safe at these levels. Another study found that AP02 was safe for both healthy volunteers and patients with IPF, a lung disease that causes scarring and breathing difficulties. Overall, the evidence so far supports that AP02 is safe and well-tolerated in humans.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about AP02 for idiopathic pulmonary fibrosis because it uses an inhalation method, potentially allowing for more targeted delivery directly to the lungs compared to oral treatments like nintedanib and pirfenidone. This targeted approach might reduce systemic side effects, which is a common concern with existing options. By offering both low and high dose inhalation forms, AP02 provides flexibility in managing the condition, potentially tailoring treatment to individual patient needs.
What evidence suggests that AP02 might be an effective treatment for IPF?
Research has shown that inhaled nintedanib, known as AP02, may help treat idiopathic pulmonary fibrosis (IPF). Previous studies found that nintedanib can slow the progression of IPF. Inhaled forms like AP02 might offer advantages by delivering the medicine directly to the lungs, potentially reducing side effects. Early results suggest that AP02 is safe and generally well tolerated, with only a few side effects reported. This trial will compare different doses of AP02 to a placebo to evaluate its effectiveness and safety, making AP02 a promising option for managing lung function in people with IPF.25678
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AP02 or placebo via nebulizer twice daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AP02
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Nintedanib solution for Inhalation
Nintedanib solution for Inhalation
Placebo solution for Inhalation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avalyn Pharma Inc.
Lead Sponsor
Citations
Avalyn Showcases Clinical Data Across Multiple ...
Topline results for AP02 (inhaled nintedanib) confirmed safety and tolerability with limited systemic exposure and substantially improved ...
A Comparison of the Effectiveness of Nintedanib and ... - PMC
The present systematic review aims at studying the efficacy of pirfenidone and nintedanib in relieving symptoms and in extending survival in patients.
An overview of AURA-IPF (AP02-003), a new trial studying ...
Results gathered from the AURA-IPF study will help researchers learn if AP02 has the potential to safely and effectively treat IPF. If the ...
phase 2 study design of inhaled nintedanib in the treatment of ...
Objective: Data from the AP02-002 study of inhaled nintedanib in healthy volunteers and IPF patients demonstrated acceptable safety in the dose ranging study.
Avalyn Pharma Reports Results of Phase 1 Study of AP02 in ...
AP02 was generally well tolerated, with no serious adverse events (SAEs) reported among the participants who were administered AP02. “We were ...
Inhaled Nintedanib (AP02) for the Treatment of IPF
CONCLUSION: AP02 was well-tolerated at single doses of up to the highest dose (2mg) and demonstrated higher BALF exposure than oral administration at the ...
Nintedanib in Idiopathic Pulmonary Fibrosis - PMC - NIH
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a median survival of ~3 years. Nintedanib (NTD) has been shown to be useful in controlling ...
Inhaled Nintedanib (AP02) for the Treatment of IPF: Safety ...
CONCLUSION: AP02 was well-tolerated at single doses of up to the highest dose (2mg) and demonstrated higher BALF exposure than oral ...
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