About this trial
Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue scarring . This will be a single-center randomized, double-blinded, placebo-controlled study of 20 weeks including up to 4 weeks for screening, followed by 12 weeks of oral artesunate treatment across 3 dose levels (dose escalation every 4 weeks), and 4 weeks of a washout (follow-up) period in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary objective of the study is to evaluate the safety and tolerability of artesunate at 3 dose levels, and to select the dose(s) to carry forward into additional clinical testing. The secondary objective includes exploring the blood biomarkers present in participants with IPF at baseline and to investigate how those biomarkers change following artesunate treatment. The exploratory objectives include assessing the changes in the K-BILD and Leicester cough questionnaire scores and change in pulmonary function after artesunate administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 years or older.
Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (56)
FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening.
Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 25%; historical DLco for entry in the study is permitted if within 3 months of screening.
Disqualifiers
Receiving any nonapproved agent intended for treatment of fibrosis in IPF or participation in other treatment clinical trials.
Clinical evidence of active infection within 30 days of screening, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening.
Known acute IPF exacerbation, or suspicion by the Investigator of such, within 3 months of screening.
The extent of emphysema is greater than the fibrotic changes on the most recent HRCT scan as determined by PI.
Trial design
Parallel
Treatments tested in this trial
Artesuante
DrugArtesunate capsules administered orally twice daily beginning at 20 mg for 4 weeks, followed by 40 mg for 4 weeks, and then 60 mg for 4 weeks.
Placebo capsules
Other interventionPlacebo capsules
Treatment groups
Trial outcomes
Primary outcomes
Number of participants who experience treatment-related adverse events
Sponsors and contacts
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Joseph C. Wu
Lead sponsor
Stanford University
Sponsor institution