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NCT05988463 | RECRUITING | Idiopathic Pulmonary Fibrosis

Dose-Escalation Study of Artesunate Patients With IPF
Sponsor:

Joseph C. Wu

Information provided by (Responsible Party):

Joseph C. Wu

Brief 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.

Condition or disease

Idiopathic Pulmonary Fibrosis

Intervention/treatment

Artesuante

Placebo capsules

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Masking Description : Randomization and masking will be done via a medical software.
Primary Purpose : TREATMENT
Official Title : A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)
Actual Study Start Date : 2027-01-01
Estimated Primary Completion Date : 2027-11-01
Estimated Study Completion Date : 2028-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Participants, aged 40 years or older.
  • 2. Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (55).
  • 3. FVC percent of predicted ≥ 40%; 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) ≥ 30%; historical DLco for entry in the study is permitted if within 3 months of screening.
  • 5. 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 defined as the highest dose tolerated by the participant during ≥ 6 weeks).
  • 6. 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 birth control during their participation in the study and for 60 days after the last administration of study drug. Highly effective methods of birth control are defined as those with 99% or greater efficacy.
  • 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).
Exclusion Criteria
  • 1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF or Participation in other clinical trials.
  • 2. Clinical evidence of active infection, 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 patients ineligible for the study, as deemed significant by PI.
  • 6. 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 phosphatase \> 2.5× ULN, pending PI's discretion.
  • 7. Hemoglobin levels \< 10.0 g/dL.
  • 8. Pregnant or lactating females.
  • 9. Likely to have lung transplantation during the study (being on transplantation list is acceptable).
  • 10. Currently receiving and expected to remain on treatment during the study with: amodiaquine, and efavirenz, nevirapine and ritonavir.
Dose-Escalation Study of Artesunate Patients With IPF

Location Details

NCT05988463

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305