A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

NCT ID: NCT00930163

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-09-30

Brief Summary

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This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).

Detailed Description

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Conditions

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Asthma

Keywords

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Adult Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

lebrikizumab (MILR1444A)

Intervention Type DRUG

Subcutaneous repeating dose

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subcutaneous repeating dose

Interventions

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lebrikizumab (MILR1444A)

Subcutaneous repeating dose

Intervention Type DRUG

placebo

Subcutaneous repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight 40 kg--150 kg
* Chest radiograph with no evidence of clinically significant abnormality
* Uncontrolled asthma

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Freemer, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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United Kingdom United States

References

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Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.

Reference Type DERIVED
PMID: 21812663 (View on PubMed)

Other Identifiers

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ILR4646g

Identifier Type: -

Identifier Source: org_study_id