Dose-Escalation Study of Artesunate Patients With IPF (NCT05988463) | Clinical Trial Compass
RecruitingPhase 1
Dose-Escalation Study of Artesunate Patients With IPF
United States15 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Participants receiving nintedanib, pirfenidone, and/or nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination therapy (e.g., nintedanib plus nerandomilast or pirfenidone plus nerandomilast), are eligible for enrollment. All background IPF therapies must be stable for at least 6 weeks prior to the Screening visit and taken continuously with no or only rare interruptions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who experience treatment-related adverse events
. Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential agree to use highly effective methods of birth control during their participation in the study and for 60 days after the last administration of study drug. Women of child-bearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
. Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug.
. Able to read and sign a written informed consent form (ICF).
Exclusion criteria
. 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.
. Any medical condition, not limited to cardiac, hepatic, renal disease or malignancy, in recent months that will make the participants unsuitable for the study, as judged by the PI.
. Any of the following liver test results above the listed specified limits: total bilirubin \>2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN; alkaline phosphatase (ALP) \> 2.5× ULN, pending PI's discretion.