Status:

COMPLETED

A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

Lead Sponsor:

Genentech, Inc.

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the effi...

Eligibility Criteria

Inclusion

  • Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
  • Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
  • Stable asthma

Exclusion

  • Asthma exacerbation during screening
  • Known malignancy
  • Known immunodeficiency
  • Pre-existing lung disease other than asthma
  • Uncontrolled clinically significant medical disease
  • Current smoker
  • History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
  • Prior allergic reaction to a monoclonal antibody
  • Patients (men and women) of reproductive potential who are not willing to use contraception
  • Pregnancy

Key Trial Info

Start Date :

November 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

210 Patients enrolled

Trial Details

Trial ID

NCT00971035

Start Date

November 1 2009

End Date

February 1 2011

Last Update

November 29 2016

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