NCT01629667

A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

Detailed description

The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Tralokinumab	Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
BIOLOGICAL	Tralokinumab	Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
OTHER	Placebo	Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-05-01
• Completion: 2016-01-01
• First posted: 2012-06-27
• Last updated: 2017-05-15
• Results posted: 2017-05-15

Locations

45 sites across 6 countries: United States, Australia, Canada, Israel, Peru, South Korea