- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988463
Open-Label Dose-Escalation Treatment Study of Patients With IPF (DIAMOND)
A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Idiopathic Pulmonary Fibrosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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).
- 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.
- Participants must agree to abstain from egg or sperm donation through 60 days, after administration of the last dose of study drug.
- Able to read and sign a written informed consent form (ICF).
Exclusion Criteria:
- 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.
- 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.
- 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.
- Hemoglobin levels < 10.0 g/dL.
- Pregnant or lactating females.
- Likely to have lung transplantation during the study (being on transplantation list is acceptable).
- Currently receiving and expected to remain on treatment during the study with: amodiaquine, and efavirenz, nevirapine and ritonavir.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artesunate
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who experience treatment-related adverse events
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua Mooney, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Interstitial
- Fibrosis
- Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Artesunate
Other Study ID Numbers
- 71488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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