A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-004919-39-DE
- Lead Sponsor
- itto Denko Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
•Forced vital capacity (FVC) = 45% of predicted.
•Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin = 30% of predicted value
•Ratio of forced expiratory volume in 1 second (FEV1) to FVC = 0.70.
Other protocol defined inclusion/exclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
•Best, acceptable FVC from separate screening spirometry that differ by = 200 mL.
•Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
•Anticipated to receive a lung transplant during the subject's participation in the study.
•Active smoker or smoking cessation within 12 weeks before screening.
•Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
•Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
•Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
•Receiving an investigational treatment, whether or not approved for marketing, with the last dose of that study drug within 8 weeks or 5 half-lives (whichever is longer) before screening. Individuals allocated to receive no treatment beyond SOC in an investigational study are not excluded from this trial.
•Pregnant or breastfeeding.
•Known history of HIV infection, active chronic hepatitis B (eg hepatitis B surface antigen positive), and/or untreated hepatitis C antigen positive patients (with or without abnormal liver enzymes). If treated for hepatitis C viral eradication, then a viral load below the limits of quantitative detection for at least 12 weeks must be documented.
•History of alcohol abuse and/or dependence within the last 2 years.
•History within the last 2 years of significant mental illness, or dependence on any opioid or illicit drugs, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
•Suspected or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, defined as meeting one or more of the following criteria:
a. The subject has known exposure to a person with signs or symptoms of SARS-CoV-2 infection or has tested positive for SARS-CoV-2 (suggesting current infection) within 21 days prior to the subject’s Visit 1a.
b. The subject has current signs and symptoms suggestive of SARS-CoV-2 infection.
c. The subject has SARS-CoV-2 virus or viral antigen detected at Visit 1a using a test approved for marketing if testing is available. (Detection of antibody to SARS-CoV-2 will not be exclusionary).
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the safety and tolerability of ND-L02-s0201, administered at 2 dose levels, Q2W over 24 weeks, versus placebo, in conjunction with standard of care (SOC);Secondary Objective: • Evaluate the biological activity of ND-L02-s0201 as measured by spirometry over 24 weeks<br>• Evaluate changes of interstitial lung abnormalities (ILA) as measured by high resolution computed tomography (HRCT)<br>• Evaluate single-dose PK endpoints over 24 weeks in a subset of subjects<br>• Evaluate trough levels for accumulation over time and identify when steady state conditions are achieved;Primary end point(s): Safety<br>• Incidence of treatment- emergent AEs (TEAEs) and treatment-emergent SAEs<br>• Proportion of subjects discontinuing study treatment due to TEAEs;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method