Artesunate for Idiopathic Pulmonary Fibrosis
(DIAMOND Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJoshua Mooney, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Joseph C. Wu

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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 . The goal of this open-label (no placebo) study is to evaluate the safety and tolerability of artesunate at three different doses in patients with IPF. The secondary goals are to explore the blood biomarkers present in IPF patients at the beginning of the study and to study how those biomarkers change following treatment with artesunate. Participants will have 7 visits to the study site over 20 weeks which will include physician exams, vital signs, questionnaires, research and safety blood samples, and taking artesunate capsules by mouth for 12 weeks. Artesunate is used world-wide for the treatment of severe malaria but has also been found to block specific proteins that cause lung scarring and may provide an additional treatment to slow the fibrotic process in the lung and improve survival and quality of life for patients with IPF.

Research Team

Joshua Mooney, MD, MS

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF), who are already on stable IPF treatments like nintedanib or pirfenidone. Participants must have a certain level of lung function and agree to use effective birth control. Those with severe other diseases, recent infections affecting lung function tests, specific liver test abnormalities, low hemoglobin levels, or taking certain drugs can't join.

Inclusion Criteria

I have been on a stable dose of nintedanib or pirfenidone for my IPF for at least 6 weeks.

I am using or willing to use effective birth control during and for 60 days after the study.

Able to read and sign a written informed consent form (ICF)

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Exclusion Criteria

I have had a sudden worsening of my lung condition in the last 3 months.

Your last chest scan showed more damage from emphysema than from fibrosis.

I don't have any major health issues that would exclude me from the study.

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Treatment Details

Interventions

Artesunate (Anti-malarial Agent)

Trial OverviewThe study is testing the safety and effects of artesunate oral capsules at three different doses in IPF patients over 20 weeks. Artesunate is known for treating malaria but may help reduce lung scarring in IPF. The study includes regular visits for exams, blood samples to check biomarkers related to fibrosis before and after treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ArtesunateExperimental Treatment1 Intervention

Artesunate is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Artesunate for: