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Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Summary

This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will consist of males and females ranging in age from 21 to 80 years old, inclusive. The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26 week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up Visit (within 4 weeks after the last dose).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02503657
Study type Interventional
Source MediciNova
Contact
Status Completed
Phase Phase 2
Start date March 9, 2016
Completion date March 15, 2022
View Details
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