NCT01402986

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 689 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Detailed description

Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Placebo Q2W	Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
BIOLOGICAL	Tralokinumab 300 mg, Q2W	Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.
OTHER	Placebo, Q2/4W	Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
BIOLOGICAL	Tralokinumab 300 mg, Q2/4W	Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-06-01
• Completion: 2014-02-01
• First posted: 2011-07-27
• Last updated: 2017-04-04
• Results posted: 2017-03-06

Locations

89 sites across 15 countries: United States, Argentina, Canada, Chile, Czechia, France, Germany, Japan, Mexico, Philippines, Poland, Russia, South Korea, Spain, United Kingdom