NCT00968669

A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

A Phase 2b, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.

Detailed description

The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous (SC) administration of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI528 30 mg	MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
BIOLOGICAL	MEDI528 100 mg	MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
BIOLOGICAL	MEDI528 300 mg	MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
OTHER	Placebo	Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2009-08-31
• Last updated: 2014-06-04
• Results posted: 2014-06-04

Locations

57 sites across 10 countries: United States, Argentina, Brazil, Canada, Colombia, Costa Rica, Panama, Peru, Philippines, Taiwan