Idiopathic Pulmonary Fibrosis study: Artesuante
Official title Dose-Escalation Study of Artesunate Patients With IPF
ClinicalTrials.gov ID: NCT05988463
What this study is testing
What is Artesuante?
An investigational oral medication being studied for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if artesunate is safe and how it affects blood markers, lung function, and cough in IPF patients.
- Who it's for
- Adults diagnosed with idiopathic pulmonary fibrosis.
- What's involved
- Participants will take oral artesunate at one of three dose levels for 12 weeks, with visits every 4 weeks for dose changes, safety checks, and tests of lung function and cough.
- Time commitment
- The study lasts about 20 weeks: up to 4 weeks for screening, 12 weeks of treatment, and 4 weeks of follow‑up, with regular clinic visits during that time.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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%
- Participants receiving nintedanib, pirfenidone, and/or nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination...
You likely can't join if
- 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...
- 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...
- Any of the following liver test results above the listed specified limits: total bilirubin \>2× the upper limit of normal (ULN)
See the full eligibility 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...
- 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...
- 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). 7.3
- 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
- Hemoglobin \< 10.0 g/dL.
- Pregnant or lactating.
- Likely to undergo lung transplantation during the study (being on transplantation list is acceptable).
- Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine, and efavirenz, nevirapine and ritonavir.
The study team makes the final eligibility decision.
Where it is enrolling
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Stanford, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.