NCT02739165

Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Phase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Asahi Kasei Therapeutics Corporation · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	ART-123	380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
DRUG	Placebo	Placebo by intravenous drip infusion in addition to standard of care steroid therapy

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2016-04-15
• Last updated: 2019-01-18

Locations

26 sites across 1 country: Japan