About The Study
Disease target: Progressive Pulmonary Fibrosis (PFF) (Formally PF-ILD)
Recruitment target: 300
Duration: 56 weeks
Study Locations
NSW
- Westmead Hospital
- Nepean Lung and Sleep
- Royal Prince Alfred Hospital
- John Hunter Hospital
VIC
- Alfred Health
- Eastern Health
- Box Hill Hospital
- Lung & Sleep Victoria
WA
- Institute for Respiratory Health
ACT
- The Canberra Hospital
New Zealand
- Canterbury Respiratory Research Group
- Greenlane Clinical Centre
- University of Otago
- Te Whatu Ora – Health New Zealand
What is involved?
This is a randomized, double-blind, placebo- controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks.
Investigational medicinal product, comparator and randomisation
- AP01 (Inhaled pirfenidone)
- Participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Can I participate?
Inclusion Criteria
- > 18 years of age
- Diagnosis of PPF
- Meeting all of the following criteria:
I. FVC ≥45% of predicted normal
II. FEV1/FVC ≥0.7 or ≥age-adjusted lower limit of normal Global Lung Function Initiative
III. DLCO ≥30% of predicted, corrected for hemoglobin
IV. Subject can perform acceptable spirometry
- Fibrosing lung disease on HRCT
- For subjects already on nintedanib must have been on it for at least 6 months
- For subjects who have discontinued nintedanib: Must have been off it for at least 12 weeks
- For subjects on background immunomodulatory therapy, they must have been on medication for 12 weeks (6 months for rituximab)
- For subjects who have discontinued rituximab: Must have received the last dose of rituximab at least 6 months prior to Screening
Exclusion Criteria
- Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months
- Elevated liver enzymes and liver injury
- Renal disease
- Diagnosis of idiopathic pulmonary fibrosis (IPF)
- Greater extent of emphysema than of fibrotic ILD on HRCT.
- Significant clinical worsening of PPF between Screening Visit 1 and Visit 3
- Avalyn AP01 MIST Trial Summary Avalyn-AP01-MIST-Trial-Summary_03022025.pdf
For Further Information or How to Participate
If you would like to take part or have any questions about this research study, please fill out our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Avalyn Pharma.
Clinicaltrials.gov ID: NCT06329401