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)

itto Denko Corporation0 sites120 target enrollmentJuly 16, 2018

ConditionsIdiopathic Pulmonary Fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: itto Denko Corporation
Enrollment: 120
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 16, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

itto Denko Corporation

Eligibility 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\.
•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

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
•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.