A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

March 3, 2015 updated by: Genentech, Inc.

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • United States
    • Alabama
      • Pell City, Alabama, United States, 35128
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Scottsdale, Arizona, United States, 85266
      • Tucson, Arizona, United States, 85712
    • California
      • Bakersfield, California, United States, 93301
      • Fountain Valley, California, United States, 92708
      • Fullerton, California, United States, 92835
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90025
      • Mission Viejo, California, United States, 92691
      • Napa, California, United States, 94558
      • Orange, California, United States, 92868
      • Rancho Mirage, California, United States, 92270
      • Sacramento, California, United States, 95819
      • San Diego, California, United States, 92108
      • Studio City, California, United States, 91607
      • Upland, California, United States, 91786
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Colorado Springs, Colorado, United States, 80907
      • Denver, Colorado, United States, 80206
      • Wheat Ridge, Colorado, United States, 80033
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Gainesville, Florida, United States, 32605
      • North Palm Beach, Florida, United States, 33408
      • Ocala, Florida, United States, 34471
      • Tallahassee, Florida, United States, 32308
      • Tampa, Florida, United States, 33613
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Albany, Georgia, United States, 31707
      • Savannah, Georgia, United States, 31406
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Illinois
      • River Forest, Illinois, United States, 60305
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Maine
      • Bangor, Maine, United States, 04401
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
    • Nevada
      • Las Vegas, Nevada, United States, 89119
      • Las Vegas, Nevada, United States, 89106
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Bronx, New York, United States, 10461
      • Great Neck, New York, United States, 11021
      • New York, New York, United States, 10016
      • Rockville Centre, New York, United States, 11570
    • North Carolina
      • High Point, North Carolina, United States, 27262
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Cincinnati, Ohio, United States, 45231
    • Oregon
      • Eugene, Oregon, United States, 97401-7721
      • Lake Oswego, Oregon, United States, 97035
      • Portland, Oregon, United States, 97202
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
      • Easton, Pennsylvania, United States, 18045
      • Harrisburg, Pennsylvania, United States, 17110
      • Philadelphia, Pennsylvania, United States, 19115
      • Upland, Pennsylvania, United States, 19013
    • Rhode Island
      • Warwick, Rhode Island, United States, 02865
    • South Carolina
      • Greenville, South Carolina, United States, 29607
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Arlington, Texas, United States, 76018
      • Dallas, Texas, United States, 75230
      • El Paso, Texas, United States, 79925
      • Fort worth, Texas, United States, 76109
      • McKinney, Texas, United States, 75069
      • San Antonio, Texas, United States, 78251
      • San Antonio, Texas, United States, 78224
    • Virginia
      • Henrico, Virginia, United States, 23233
    • Washington
      • Seattle, Washington, United States, 98105
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18 to 75 years of age at Visit 1
  • Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)
  • Bronchodilator response during screening
  • Pre-bronchodilator FEV1 40%-80% of predicted during screening
  • On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for >/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
  • On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
  • Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
  • Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
  • Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

  • History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of zileuton or roflumilast within 6 months prior to screening
  • Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
  • Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
  • Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
  • Active parasitic infection within the 6 months prior to Visit 1
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Known immunodeficiency, including, but not limited to, HIV infection
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
  • Known malignancy or current evaluation for a potential malignancy
  • Current smoker or former smoker with a history >10 pack years
  • History of alcohol, drug or chemical abuse
  • Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
  • Use of biologic therapy including omalizumab during 6 months prior to Visit 1
  • Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
  • Pregnant or lactating women
  • Body mass index (BMI) > 38 kg/m2
  • Body weight < 40 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - highest dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - lowest dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - middle dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of asthma exacerbations during the 52-week placebo-controlled period
Time Frame: weeks 0-52
weeks 0-52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in lung function: pre-bronchodilator FEV1
Time Frame: from baseline to week 52
from baseline to week 52
Time to first asthma exacerbation
Time Frame: from baseline to week 52
from baseline to week 52
Change in fractional exhaled nitric oxide (FeNO)
Time Frame: from baseline to week 52
from baseline to week 52
Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])
Time Frame: from baseline to week 52
from baseline to week 52
Change in asthma rescue medication use
Time Frame: from baseline to week 52
from baseline to week 52
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Time Frame: from baseline to week 52
from baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB27862
  • 2011-004218-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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