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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

NCT01402986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 689

Last updated 2017-04-04

Study results available
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Summary

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Conditions

Interventions

OTHER

Placebo Q2W

Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

BIOLOGICAL

Tralokinumab 300 mg, Q2W

Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.

OTHER

Placebo, Q2/4W

Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

BIOLOGICAL

Tralokinumab 300 mg, Q2/4W

Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Edward Piper, MBBS · Sponsor GmbH

  • Christopher Brightling · Institute for Lung Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-06-30
Completion
2014-02-28

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT01402986 on ClinicalTrials.gov