NCT02054130

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 584 (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 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo	Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
DRUG	MEDI9929 70 mg	Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
DRUG	MEDI9929 210 mg	Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
DRUG	MEDI9929 280 mg	Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Timeline

• Start date: 2013-12-13
• Primary completion: 2016-12-12
• Completion: 2017-03-01
• First posted: 2014-02-04
• Last updated: 2018-12-04
• Results posted: 2018-12-04

Locations

107 sites across 12 countries: United States, Bulgaria, Czechia, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, Slovakia, South Africa, Ukraine