Status:
NOT_YET_RECRUITING
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Lead Sponsor:
Avalyn Pharma Inc.
Conditions:
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07194382
Start Date
January 1 2026
End Date
June 1 2027
Last Update
September 26 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.