A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
NCT ID: NCT01545453
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE2
205 participants
INTERVENTIONAL
2012-03-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lebrikizumab - highest dose
lebrikizumab
subcutaneous dose every 4 weeks
lebrikizumab - lowest dose
lebrikizumab
subcutaneous dose every 4 weeks
lebrikizumab - middle dose
lebrikizumab
subcutaneous dose every 4 weeks
placebo
placebo
subcutaneous dose every 4 weeks
Interventions
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lebrikizumab
subcutaneous dose every 4 weeks
lebrikizumab
subcutaneous dose every 4 weeks
lebrikizumab
subcutaneous dose every 4 weeks
placebo
subcutaneous dose every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Oxford, Alabama, United States
Long Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
Redwood City, California, United States
San Mateo, California, United States
Stockton, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Panama City, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Woodstock, Georgia, United States
Twin Falls, Idaho, United States
Normal, Illinois, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Overland Park, Kansas, United States
Baltimore, Maryland, United States
Brockton, Massachusetts, United States
Bay City, Michigan, United States
Novi, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Brick, New Jersey, United States
Edison, New Jersey, United States
Ocean City, New Jersey, United States
Teaneck, New Jersey, United States
Verona, New Jersey, United States
North Syracuse, New York, United States
Canton, Ohio, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Altoona, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Austin, Texas, United States
Austin, Texas, United States
Boerne, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Sugar Land, Texas, United States
Murray, Utah, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Brisbane, Queensland, Australia
Countries
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References
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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.
Hanania 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.
Related Links
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study website
Other Identifiers
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2011-004205-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB27864
Identifier Type: -
Identifier Source: org_study_id