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

NCT01238861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 964

Last updated 2016-11-17

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • MedImmune Ltd

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Donald Raible, MD · 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
2010-12-31
Primary Completion
2013-03-31
Completion
2013-08-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Mexico
  • Peru
  • Poland
  • Russia

Study Locations

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Entities

Diseases

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 NCT01238861 on ClinicalTrials.gov