A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)
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
2 other identifiers
interventional
258
2 countries
71
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Mar 2012
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 5, 2015
March 1, 2015
1 year
March 1, 2012
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of asthma exacerbations during the 52-week placebo-controlled period
weeks 0-52
Secondary Outcomes (6)
Change in lung function: pre-bronchodilator FEV1
from baseline to week 52
Time to first asthma exacerbation
from baseline to week 52
Change in fractional exhaled nitric oxide (FeNO)
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])
from baseline to week 52
Change in asthma rescue medication use
from baseline to week 52
- +1 more secondary outcomes
Study Arms (4)
lebrikizumab - highest dose
EXPERIMENTALlebrikizumab - lowest dose
EXPERIMENTALlebrikizumab - middle dose
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (71)
Unknown Facility
Pell City, Alabama, 35128, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Scottsdale, Arizona, 85266, United States
Unknown Facility
Tucson, Arizona, 85712, United States
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Bakersfield, California, 93301, United States
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Fountain Valley, California, 92708, United States
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Fullerton, California, 92835, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Mission Viejo, California, 92691, United States
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Napa, California, 94558, United States
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Orange, California, 92868, United States
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Rancho Mirage, California, 92270, United States
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Sacramento, California, 95819, United States
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San Diego, California, 92108, United States
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Studio City, California, 91607, United States
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Upland, California, 91786, United States
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Walnut Creek, California, 94598, United States
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Centennial, Colorado, 80112, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80206, United States
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Wheat Ridge, Colorado, 80033, United States
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Waterbury, Connecticut, 06708, United States
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Gainesville, Florida, 32605, United States
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North Palm Beach, Florida, 33408, United States
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Ocala, Florida, 34471, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33613, United States
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Winter Park, Florida, 32789, United States
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Albany, Georgia, 31707, United States
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Savannah, Georgia, 31406, United States
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Honolulu, Hawaii, 96814, United States
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River Forest, Illinois, 60305, United States
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Topeka, Kansas, 66606, United States
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Metairie, Louisiana, 70006, United States
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Bangor, Maine, 04401, United States
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Kansas City, Missouri, 64114, United States
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Bellevue, Nebraska, 68123, United States
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Las Vegas, Nevada, 89106, United States
Unknown Facility
Las Vegas, Nevada, 89119, United States
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Albuquerque, New Mexico, 87131, United States
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Great Neck, New York, 11021, United States
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New York, New York, 10016, United States
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Rockville Centre, New York, 11570, United States
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The Bronx, New York, 10461, United States
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High Point, North Carolina, 27262, United States
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Wilmington, North Carolina, 28401, United States
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Cincinnati, Ohio, 45231, United States
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Eugene, Oregon, 97401-7721, United States
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Lake Oswego, Oregon, 97035, United States
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Portland, Oregon, 97202, United States
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Blue Bell, Pennsylvania, 19422, United States
Unknown Facility
Easton, Pennsylvania, 18045, United States
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Harrisburg, Pennsylvania, 17110, United States
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Philadelphia, Pennsylvania, 19115, United States
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Upland, Pennsylvania, 19013, United States
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Warwick, Rhode Island, 02865, United States
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Greenville, South Carolina, 29607, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Arlington, Texas, 76018, United States
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Dallas, Texas, 75230, United States
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El Paso, Texas, 79925, United States
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Fort Worth, Texas, 76109, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78224, United States
Unknown Facility
San Antonio, Texas, 78251, United States
Unknown Facility
Henrico, Virginia, 23233, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Nedlands, Western Australia, 6009, Australia
Related Publications (2)
Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.
PMID: 33217063DERIVEDHanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, Cheu M, Putnam WS, Murray E, Scheerens H, Holweg CT, Maciuca R, Gray S, Doyle R, McClintock D, Olsson J, Matthews JG, Yen K. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015 Aug;70(8):748-56. doi: 10.1136/thoraxjnl-2014-206719. Epub 2015 May 22.
PMID: 26001563DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 6, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
July 1, 2013
Last Updated
March 5, 2015
Record last verified: 2015-03