Dose-Escalation Study of Artesunate Patients With IPF

NCT ID: NCT05988463

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-01
• Study Completion Date: 2028-11-01

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate

Experimental group

Group Type: EXPERIMENTAL

Artesuante

Intervention Type: DRUG

Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks.

Placebo capsules

Intervention Type: OTHER

Placebo capsules

Placebo

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Artesuante

Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks.

Intervention Type: DRUG

Placebo capsules

Placebo capsules

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph C. Wu

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Wu

Director, Stanford Cardiovascular Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joshua Mooney, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph Wu, M.D, Ph.D.

Role: CONTACT

joewu@stanford.edu

(650) 736-2246

Evgenios Neofytou, M.D.

Role: CONTACT

neofytou@stanford.edu

6507363346

Other Identifiers

71488

Identifier Type: -

Identifier Source: org_study_id