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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF (NCT07194382) is a Phase 2 interventional studying Idiopathic Pulmonary Fibrosis (IPF), sponsored by Avalyn Pharma Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Idiopathic Pulmonary Fibrosis (IPF) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Idiopathic Pulmonary Fibrosis (IPF) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patients aged ≥40 years at the time of signing the written willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Treatments Being Tested

DRUG

AP02

Oral inhalation solution

DRUG

Placebo

Placebo oral inhalation solution

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nepean Lung and Sleep

Kingswood, New South Wales, Australia

Dynamic Drug Advancement

Ajax, Ontario, Canada

CIC Mauricie

Trois-Rivières, Quebec, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07194382), the sponsor (Avalyn Pharma Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07194382 clinical trial studying?

Who can participate in NCT07194382?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07194382?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07194382. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07194382. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.