Malaria drug artesunate tested for lung scarring
NCT ID NCT05988463
First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This early-stage trial tests whether artesunate, a drug used for malaria, is safe for people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. Fifteen adults with IPF will receive either artesunate capsules or a placebo for 12 weeks, with the dose increasing every 4 weeks. The main goal is to check for side effects and find a safe dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- artesunate
- What this could lead to
- If safe, this could point toward a new treatment option for IPF, a lung-scarring disease with few therapies.
- What could go wrong
- This is a very early, small phase 1 safety trial with only 15 people. It is not designed to prove effectiveness, and many early drugs fail to show benefit in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Each participant must meet the following criteria to be enrolled in this study: 1. Age 40 years or older. 2. Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (56) 3. FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening. 4. 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. 5. 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. 6. 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. Highly effective methods of birth control are defined as those with 99% or greater efficacy and includes: Use of hormonal contraception that inhibits ovulation, administered orally, by injection, implant, transdermal patch, or vaginal ring Vasectomized male partner Sexual abstinence, only if it is the participant's consistent and preferred lifestyle Infertile partner, confirmed by medical evaluation 7. Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug. 8. Able to read and sign a written informed consent form (ICF). 7.3 Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study. 1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF or participation in other treatment clinical trials. 2. 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. 3. Known acute IPF exacerbation, or suspicion by the Investigator of such, within 3 months of screening. 4. The extent of emphysema is greater than the fibrotic changes on the most recent HRCT scan as determined by PI. 5. 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. 6. 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. 7. Hemoglobin \< 10.0 g/dL. 8. Pregnant or lactating. 9. Likely to undergo lung transplantation during the study (being on transplantation list is acceptable). 10. Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine, and efavirenz, nevirapine and ritonavir.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGStanford, California, 94305, United States
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