JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
NCT ID: NCT03538301
Last Updated: 2023-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2018-06-18
2022-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose Level 1
ND-L02-s0201 45mg
ND-L02-s0201 (Low Dose)
Intravenous administration every 2 weeks
Dose Level 2
ND-L02-s0201 90mg
ND-L02-s0201 (High Dose)
Intravenous administration every 2 weeks
Placebo
Control Arm
Other: Placebo
Saline
Interventions
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ND-L02-s0201 (Low Dose)
Intravenous administration every 2 weeks
ND-L02-s0201 (High Dose)
Intravenous administration every 2 weeks
Other: Placebo
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
* Pregnant or breastfeeding.
* Medical history of infection with HIV, hepatitis B, or hepatitis C.
* History of alcohol abuse and/or dependence within the last 2 years.
* History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.
40 Years
80 Years
ALL
No
Sponsors
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Nitto Denko Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nitto Denko Corporation
Role: STUDY_DIRECTOR
Nitto Denko Corporation
Locations
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Banner-University Medical Center Tucson Campus
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, United States
Norton Clinical Research Group
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, United States
Duke University Hospital
Durham, North Carolina, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT Health San Antonio: First Outpatient Research Unit
San Antonio, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Universitatsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Justus-Liebig-Universitaet Giessen
Giessen, Hesse, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Ruhrlandklinik, Universitatmedzin Essen
Essen, North Rhine-Westphalia, Germany
National Hospital Organization Himeji Medical Center
Himeji-Shi, Hyōgo, Japan
National Hospital Organization Ibarakihigashi National Hospital
Naka-gun, Ibaraki, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Osaka, Sakai-shi, Japan
Tosei General Hospital
Aichi, Seto-shi, Japan
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ND-L02-s0201-005
Identifier Type: -
Identifier Source: org_study_id