JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

Key facts

Study ID

NCT03538301

Run by

Nitto Denko Corporation

People needed

123

Starts

2018-06-18

Expected to finish

2022-08-24

Last updated by the study team

2023-12-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.
• Other protocol defined inclusion/exclusion criteria could apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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