MedTrace Logo

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

NCT02054130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2018-12-04

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune LLC · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-13
Primary Completion
2016-12-12
Completion
2017-03-01

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Israel
  • Japan
  • Latvia
  • Lithuania
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054130 on ClinicalTrials.gov