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Open-Label Dose-Escalation Treatment Study of Patients With IPF (DIAMOND)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Artesunate Oral Product
Sponsored by
Joseph C. Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring shortness of breath, fibrosis, cough, hypoxemia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artesunate

Arm Description

Outcomes

Primary Outcome Measures

Number of participants who experience treatment-related adverse events

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
Joseph C. Wu
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1. Study Identification

Unique Protocol Identification Number
NCT05988463
Brief Title
Open-Label Dose-Escalation Treatment Study of Patients With IPF
Acronym
DIAMOND
Official Title
A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph C. Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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 . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
shortness of breath, fibrosis, cough, hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open label, dose escalation treatment study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artesunate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Artesunate Oral Product
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who experience treatment-related adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Mooney, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open-Label Dose-Escalation Treatment Study of Patients With IPF

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