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JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years - 80 Years
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Nitto Denko Corporation
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Nitto Denko Corporation
Principal Investigator Affiliation
Nitto Denko Corporation
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Germany, Japan, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Experimental: ND-L02-s0201 (Dose Level 1)
Experimental: ND-L02-s0201 (Dose Level 2)
Placebo Comparator: Placebo
Interventions
Drug: - ND-L02-s0201
Intravenous administration every 2 weeks
Drug: - ND-L02-s0201
Intravenous administration every 2 weeks
Other: - Other: Placebo
Saline
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
