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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 study is for patients 40-80 years of age with IPF (idiopathic pulmonary fibrosis). This study is being done to learn more about an experimental medication which is being developed to treat fibrosis or scarring of the lungs. The purpose of this study is to evaluate the safety of this experimental medication when administered at two dose levels compared with placebo (injection containing no active medication).
Donna Griffiths at dgriffiths@pennstatehealth.psu.edu or 717-531-5519
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03538301
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Inclusion Criteria:
Must be 40-80 years of age
Have a diagnosis of IPF within the past 5 years
Unchanged dose of pirfenidone or nintedanib for at least 12 weeks if currently taking these medications
Exclusion Criteria:
Respiratory exacerbation or hospitalization in the last 3 months
Taking both pirfenidone and nintedanib simultaneously in the past 12 weeks
Lung transplant anticipated during the study
Known history of liver cirrhosis
Active smoker or cessation in the past 12 weeks
Lung Disease & Asthma
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Study Locations

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Location
Hershey, PA