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Tests treatment safety and results for Idiopathic Pulmonary Fibrosis (IPF)
Official title AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
ClinicalTrials.gov ID: NCT07194382
What this study is testing
What is AP02?
AP02 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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/...
- 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...
- Forced vital capacity (FVC) ≥45% predicted of normal
You likely can't join if
- Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kingswood, New South Wales, Australia
- Ajax, Ontario, Canada
- Trois-Rivières, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingswood, New South Wales, Australia; Ajax, Ontario, Canada; Trois-Rivières, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.