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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538301
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Nitto Denko Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: ND-L02-s0201 Other: Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: ND-L02-s0201 (Dose Level 1) Drug: ND-L02-s0201
Intravenous administration every 2 weeks

Experimental: ND-L02-s0201 (Dose Level 2) Drug: ND-L02-s0201
Intravenous administration every 2 weeks

Placebo Comparator: Placebo Other: Other: Placebo
Saline




Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks ]

Secondary Outcome Measures :
  1. Evaluate the biological activity of ND-L02-s0201 as measured by spirometry [ Time Frame: Baseline vs. 24 weeks ]
  2. Evaluate changes of interstitial lung abnormalities as measured by HRCT [ Time Frame: Baseline vs. 24 weeks ]
  3. Evaluate maximum plasma concentration (Cmax) [ Time Frame: Over 24 weeks ]
  4. Evaluate time to maximum plasma concentration (Tmax) [ Time Frame: Over 24 weeks ]
  5. Evaluate area under the plasma concentration-time curve (AUC) [ Time Frame: Over 24 weeks ]
  6. Evaluate area under the first moment of the plasma concentration-time curve (AUMC) [ Time Frame: Over 24 weeks ]
  7. Evaluate total plasma clearance of drug (CL) [ Time Frame: Over 24 weeks ]
  8. Evaluate apparent terminal elimination rate constant (Kel) [ Time Frame: Over 24 weeks ]
  9. Evaluate volume of distribution at steady state (Vss) [ Time Frame: Over 24 weeks ]
  10. Evaluate volume of distribution during the elimination phase (Vz) [ Time Frame: Over 24 weeks ]
  11. Evaluate apparent terminal elimination half-life (T1/2) [ Time Frame: Over 24 weeks ]
  12. Evaluate trough plasma concentration (Ctrough) [ Time Frame: Over 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538301


Contacts
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Contact: Contact recruiting sites directly for detail information. If there is no contact listed; +81-3-6632-2069 nitto-005-study@rrdintl.com

Locations
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Sponsors and Collaborators
Nitto Denko Corporation
Investigators
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Study Director: Nitto Denko Corporation Nitto Denko Corporation
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Responsible Party: Nitto Denko Corporation
ClinicalTrials.gov Identifier: NCT03538301    
Other Study ID Numbers: ND-L02-s0201-005
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial