NCT02161757

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,207 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

Detailed description

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Conditions

• Uncontrolled Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Tralokinumab	Subcutaneous injection
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2014-06-13
• Primary completion: 2017-02-28
• Completion: 2017-07-18
• First posted: 2014-06-12
• Last updated: 2018-08-28
• Results posted: 2018-04-17

Locations

243 sites across 15 countries: United States, Argentina, Belgium, Bulgaria, Colombia, Germany, Hungary, Peru, Poland, Slovakia, South Korea, Spain, Taiwan, Ukraine, Vietnam

Regulatory

• FDA-regulated drug study