AP02 (inhaled nintedanib) for idiopathic pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind Phase 2 trial comparing two doses of inhaled nintedanib (AP02) against placebo in adults with IPF. Participants who are 40 years or older and meet lung function criteria will be randomized to one of three groups and will inhale study medication or placebo twice daily via nebulizer for 12 weeks. The study will measure changes in lung function and key fibrosis-related endpoints and will monitor safety and tolerability. Subjects will attend six in-person visits and receive one phone call over a 16-week period.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Recruiting
• Nepean Lung and Sleep
  Kingswood, New South Wales, Australia Recruiting
• John Hunter Hospital
  New Lambton Heights, New South Wales, Australia Recruiting
• Macquarie University Hospital
  Sydney, New South Wales, Australia Recruiting
• Ludwig Engel Centre for Respiratory Research
  Westmead, New South Wales, Australia Recruiting
• Launceston Respiratory and Sleep Centre
  Launceston, Tasmania, Australia Recruiting

Study contacts

• Study coordinator: Craig S Conoscenti, MD, FCCP, ATSF
• Email: AP02-003regulatory@avalynpharma.com
• Phone: 206-707-0340

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.