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A Placebo-Controlled Study of Inhaled Pirfenidone in Progressive Pulmonary Fibrosis
EU CTIS ID: 2023-508429-29-00
What this study is testing
To evaluate the effect of AP01 compared to AP01 placebo (hereafter referred to as placebo) on lung function over 52 weeks in subjects with PPF
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand and sign a written informed consent form (ICF) consistent with International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) and local laws prior to study enrollment.
- Able to understand the importance of adherence to study drug and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study.
- Male or female at least 18 years of age at Screening.
- Subject meets criteria for PPF (modified from Flaherty et al, 2019), as follows: In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator): a. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments b. Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria: • Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR • Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example: o Increased extent or severity of traction bronchiectasis and bronchiolectasis o New ground-glass opacity with traction bronchiectasis o New fine reticulation o Increased extent or increased coarseness of reticular abnormality o New or increased honeycombing o Increased lobar volume loss c. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist as indicated in criterion 4b above
You likely can't join if
- Current treatment with oral pirfenidone or nerandomilast at the 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.
- Elevated liver enzymes and liver injury at Screening defined as: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃3 times the upper limit of normal (ULN), OR b. Bilirubin >2.0 x ULN
- Renal disease with a creatinine clearance <30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (Inker et al, 2021). Retesting is allowed once.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. Usual interstitial pneumonia (UIP) that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.
- Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
- Significant clinical worsening of PPF between Screening Visit 1 and Visit 3 (Week 0/Day 1/Randomization), as assessed by the Investigator.
See the full eligibility criteria
Who can join
- Able to understand and sign a written informed consent form (ICF) consistent with International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) and local laws prior to study enrollment.
- Able to understand the importance of adherence to study drug and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study.
- Male or female at least 18 years of age at Screening.
- Subject meets criteria for PPF (modified from Flaherty et al, 2019), as follows: In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator): a. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments b. Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria: • Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR • Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example: o Increased extent or severity of traction bronchiectasis and bronchiolectasis o New ground-glass opacity with traction bronchiectasis o New fine reticulation o Increased extent or increased coarseness of reticular abnormality o New or increased honeycombing o Increased lobar volume loss c. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist as indicated in criterion 4b above
What rules you out
- Current treatment with oral pirfenidone or nerandomilast at the 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.
- Elevated liver enzymes and liver injury at Screening defined as: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃3 times the upper limit of normal (ULN), OR b. Bilirubin >2.0 x ULN
- Renal disease with a creatinine clearance <30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (Inker et al, 2021). Retesting is allowed once.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. Usual interstitial pneumonia (UIP) that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.
- Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
- Significant clinical worsening of PPF between Screening Visit 1 and Visit 3 (Week 0/Day 1/Randomization), as assessed by the Investigator.
- History of acute respiratory exacerbation requiring hospitalization within 12 weeks prior to Screening or at any time during the Screening Period.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Australia
- New Zealand
- United States
- Turkey
- Canada
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Australia; New Zealand; United States; Turkey; Canada and 1 more location(s). 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 EU CTIS; the study team decides eligibility.