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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:3/28/2019
Start Date:June 18, 2018
End Date:January 2021
Contact:Contact recruiting sites directly for detail information. If there is no contact listed;
Email:nitto-005-study@rrdintl.com
Phone:+81-3-6632-2069

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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)

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.


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.
We found this trial at
17
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kevin Gibson, MD
Phone: 412-692-2149
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Srihari Veeraraghavan, MD
Phone: 404-727-2011
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Leo Ginns, MD
Phone: 617-726-1082
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Ivan Rosas, MD
Phone: 617-525-7654
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Jeremy Falk, MD
Phone: 310-423-4765
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Daniel Haim, MD
Phone: 407-841-1100
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Orlando, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: J.Terrill Huggins, MD
Phone: 843-792-8092
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Corey Kershaw, MD
Phone: 214-645-7108
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Durham, North Carolina 27705
Principal Investigator: Lake Morrison, MD
Phone: 919-668-8854
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Hershey, Pennsylvania 17033
Principal Investigator: Rebecca Bascom, MD
Phone: 717-531-5519
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Hershey, PA
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Tarik Haddad, MD
Phone: 904-953-7898
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Lebanon, New Hampshire 03756
Principal Investigator: Richard Enelow, MD
Phone: 603-650-4711
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
Principal Investigator: John Belperio, MD
Phone: 310-795-8595
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Manchester,
Principal Investigator: Nazia Chaudhuri, MD
Phone: 44 0161 946 4059
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Minneapolis, Minnesota 55455
Principal Investigator: Hyun Kim, MD
Phone: 612-625-7719
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Minneapolis, MN
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50 North Medical Drive
Salt Lake City, Utah 84132
Principal Investigator: Mary Beth Scholand, MD
Phone: 412-692-2149
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San Francisco, California 94143
Principal Investigator: Jeffrey Golden, MD
Phone: 415-476-7054
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