NCT01238861

Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 964 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

Detailed description

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (MEDI-563) in adult subjects with uncontrolled asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Benralizumab 2 mg	EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
BIOLOGICAL	Benralizumab 20 mg	EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
BIOLOGICAL	Benralizumab 100 mg	EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
OTHER	Placebo	EOS+ and EOS- participants received two placebo injections subcutaneously.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2010-11-11
• Last updated: 2016-11-17
• Results posted: 2016-11-17

Locations

74 sites across 10 countries: United States, Argentina, Brazil, Bulgaria, Canada, Colombia, Mexico, Peru, Poland, Russia