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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Level 1
ND-L02-s0201 45mg
  • Drug: ND-L02-s0201 (Low Dose)
    Intravenous administration every 2 weeks
    Other names:
    • 45mg
Experimental
Dose Level 2
ND-L02-s0201 90mg
  • Drug: ND-L02-s0201 (High Dose)
    Intravenous administration every 2 weeks
    Other names:
    • 90mg
Placebo Comparator
Placebo
Control Arm
  • Other: Other: Placebo
    Saline

Recruiting Locations

More Details

NCT ID
NCT03538301
Status
Completed
Sponsor
Nitto Denko Corporation

Detailed Description

All subjects were treated with ND-L02-s0201 or placebo for 24 weeks (a total of 12 doses). Subject's participation in the study was approximately 40 weeks including a Screening and Baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after the last study treatment), and a follow-up period of 10 weeks after End-of-Treatment (EOT).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.