Purpose

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.

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
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

Recruiting Locations

Trials Today and nearby locations

Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
Contact:
Donna Griffiths
717-531-0003
dgriffiths@pennstatehealth.psu.edu

Duke University Hospital
Durham, North Carolina 27708
Contact:
Shannon Tilley
919-668-8854
shannon.tilley@duke.edu

Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire 03756
Contact:
Kathy Dickie
603-650-4711
kathy.a.dickie@hitchcock.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Michelle Myers
412-692-2149
meyersma@upmc.edu

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Amy Chamberlain
843-792-3162
chambeam@musc.edu

University of Utah Health
Salt Lake City, Utah 84108
Contact:
Joseph Martinez
801-213-2650
Joseph.Martinez@utah.edu

UT Health San Antonio: First Outpatient Research Unit
San Antonio, Texas 78229
Contact:
Hilda Pomroy
210-450-9022
pomroy@uthscsa.edu

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Rhoda Annoh Gordon
214-645-7108
Rhoda.AnnohGordon@utsouthwestern.edu

University of Minnesota Medical School
Minneapolis, Minnesota 55455
Contact:
Tommy Goodwin
612-625-7719
goodw020@umn.edu

Brigham & Women's Hospital
Boston, Massachusetts 02115
Contact:
Sam Wong
617-525-7654
ywong6@bwh.harvard.edu

Mayo Clinic Florida
Jacksonville, Florida 32224
Contact:
Judy Olmos
904-953-7898
Olmos.Judy@mayo.edu

University of California, San Francisco, Medical Center at Parnassus
San Francisco, California 94143
Contact:
Reed Norris
415-476-7054
Reed.Norris@ucsf.edu

David Geffen School of Medicine at UCLA
Los Angeles, California 90095
Contact:
Paul Lopez
310-795-8595
PLopez@mednet.ucla.edu

Central Florida Pulmonary Group, PA
Orlando, Florida 32803
Contact:
Sharon Foust
407-841-1100
sfoust@cfpulmonary.com

Emory University
Atlanta, Georgia 30322
Contact:
Tracy Halaby
404-712-7458
tracy.halaby@emory.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Mamary Kone
617-726-1082
mkone@mgh.harvard.edu

Norton Clinical Research Group
Louisville, Kentucky 40218
Contact:
Nancy McDonald
502-479-1217
nancy.mcdonald@nortonhealthcare.org

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Susan Jackman
310-423-4765
Susan.Jackman@cshs.org

More Details

NCT ID
NCT03538301
Status
Recruiting
Sponsor
Nitto Denko Corporation

Study Contact

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

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.