NCT00394654

A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy of MEDI-528, a Humanized Anti-Interleukin-9 Monoclonal Antibody, on Late Asthmatic Response Induced By Allergen Inhalation In Adults With Atopic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.

Detailed description

This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-528 9 mg/kg	MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
OTHER	Placebo	Placebo administered as a single intravenous infusion

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-08-01
• Completion: 2008-01-01
• First posted: 2006-11-01
• Last updated: 2013-12-11
• Results posted: 2013-12-11

Locations

3 sites across 1 country: Canada