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

a study on Fibrosis Idiopathic Pulmonary Fibrosis

Summary

for people ages 40-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Jeffrey Golden, MD

Description

Summary

This phase 2 clinical study will be a 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.

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)

Keywords

Idiopathic Pulmonary Fibrosis Fibrosis Pulmonary Fibrosis Idiopathic Interstitial Pneumonias

Eligibility

You can join if…

Open to people ages 40-80

  • 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 CAN'T join 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.

Locations

  • University of California, San Francisco, Medical Center at Parnassus accepting new patients
    San Francisco California 94143 United States
  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist

  • Jeffrey Golden, MD
    Professor, Medicine. Authored (or co-authored) 84 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nitto Denko Corporation
ID
NCT03538301
Phase
Phase 2
Study Type
Interventional
Last Updated