Dose-Escalation Study of Artesunate Patients With IPF

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorJoseph C. Wu

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Artesuante
  • Placebo capsules

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Joseph C. Wu

Lead sponsor

Stanford University

Sponsor institution