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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Dose-Escalation Study of Artesunate Patients With IPF
ClinicalTrials.gov ID: NCT05988463
What this study is testing
What is Artesuante?
Artesuante is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment 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
- 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).
- 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
- Participants, aged 40 years or older.
- Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (55).
- FVC percent of predicted ≥ 40%; 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) ≥ 30%; historical DLco for entry in the study is permitted if within 3...
- Participants currently receiving treatment for IPF with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose...
You likely can't join if
- Receiving any nonapproved agent intended for treatment of fibrosis in IPF or Participation in other clinical trials.
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during...
- 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 patients ineligible for the...
- Any of the following liver function test criteria above specified limits: total bilirubin \>2× the upper limit of normal (ULN); aspartate...
See the full eligibility criteria
- Participants, aged 40 years or older.
- Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (55).
- FVC percent of predicted ≥ 40%; 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) ≥ 30%; historical DLco for entry in the study is permitted if within 3 months of screening.
- Participants currently receiving treatment for IPF with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose for at least 6 weeks before the Screening visit (stable dose is...
- Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential must use highly effective methods of...
- 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).
- Receiving any nonapproved agent intended for treatment of fibrosis in IPF or Participation in other clinical trials.
- Clinical evidence of active infection, 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 patients ineligible for the study, as deemed significant by PI.
- Any of the following liver function test criteria above specified limits: total bilirubin \>2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN; alkaline...
- Hemoglobin levels \< 10.0 g/dL.
- Pregnant or lactating females.
- Likely to have lung transplantation during the study (being on transplantation list is acceptable).
- Currently receiving and expected to remain on treatment during the study with: amodiaquine, and efavirenz, nevirapine and ritonavir.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.