Recruitment Target:
- Australian target – 20 participants
- Global target – 94 participants
Duration: 42-day screening period + 26 weeks + 30 days follow-up
Study Locations
- Closed to recruitment
About the Study
The purpose of this study is to look at how well the study treatment (LTP001) works and if it is safe and effective in participants with IPF. LTP001 is an oral medication taken every morning for the duration of the study.
Can I Participate?
Inclusion Criteria
- Male and female participants at least 40 years of age
- IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guideline for diagnosis and management, within 5 years of screening
- FVC ≥45% predicted at screening with no clinically significant deterioration between the screening visit and randomization, as determined by the investigator.
- DLCO, corrected for haemoglobin, ≥25% predicted (inclusive) at screening with no clinically significant deterioration between the screening visit and randomization, as determined by the investigator.
- Unlikely to die from cause other than IPF within the next 2 years, in the opinion of the investigator
- Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
- If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
Exclusion Criteria
- Unable to perform PFTs, 6MWT or undergo HRCT procedure at time of screening
- Peripheral capillary oxygen saturation (SpO2) <90% at rest (if on supplemental oxygen, must be ≤2 L/min at rest)
- Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening as defined by an absolute increase of ≥12% and an increase of ≥200ml in FEV1 or FVC, or both, after bronchodilator use, compared with the values before bronchodilator use at screening.
- Emphysema >20% on screening HRCT as assessed visually by Fibrosis <10% on screening HRCT as assessed visually by central reader.
- Clinical diagnosis of any connective tissue disease (including but not limited to scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the investigator applying the recent ERS/ ATS research statement
- Other known causes of interstitial lung disease (e.g. domestic or occupational environmental exposures, drug toxicity) or another identifiable interstitial lung disease
- Novartis Trial Summary Novartis-PACT-trial-summary.pdf
Further information or how to take part
If you have any questions about this research study, please fill out our “Patient Trial Enquiry Form” form or email enquiries@pactnetwork.com.au.
This study is sponsored by Novartis.
Clinicaltrials.gov ID: NCT06097260