Actively Recruiting
Dose-Escalation Study of Artesunate Patients With IPF
Led by Joseph C. Wu · Updated on 2026-01-09
15
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose-Escalation Study of Artesunate Patients With IPF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 40 years or older
- Diagnosis of IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- Forced vital capacity (FVC) percent predicted of 40% or higher; historical FVC allowed if within 3 months
- Diffusing capacity of lung for carbon monoxide (DLco) adjusted for hemoglobin 30% or higher; historical DLco allowed if within 3 months
- Participants on stable doses of nintedanib or pirfenidone for at least 6 weeks before screening are allowed
- Female participants of childbearing potential and males with partners of childbearing potential must use highly effective birth control during and for 60 days after study drug
- Agree to abstain from egg or sperm donation during and for 60 days after study drug
- Able to read and sign informed consent form
You will not qualify if you...
- Receiving any nonapproved IPF fibrosis treatment or participating in other clinical trials
- Active infection such as bronchitis, pneumonia, or sinusitis affecting lung function at screening
- Acute IPF exacerbation or suspected exacerbation within 3 months before screening
- Extent of emphysema greater than fibrotic changes on recent HRCT scan
- Significant medical conditions like cardiac, liver, kidney disease, or recent malignancy as judged by investigator
- Abnormal liver function tests above specified limits
- Hemoglobin levels below 10.0 g/dL
- Pregnant or breastfeeding females
- Likely to have lung transplantation during the study (being on transplant list allowed)
- Currently receiving or expected to receive amodiaquine, efavirenz, nevirapine, or ritonavir during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
J
Joseph Wu, M.D, Ph.D.
CONTACT
E
Evgenios Neofytou, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here