- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545453
A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
November 1, 2016 updated by: Genentech, Inc.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety 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
Study Type
Interventional
Enrollment (Actual)
205
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
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Queensland
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Brisbane, Queensland, Australia, 4075
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Alabama
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Oxford, Alabama, United States, 36203-7190
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California
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Long Beach, California, United States, 90808
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Los Angeles, California, United States, 90025
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Orange, California, United States, 92868
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Redwood City, California, United States, 94063
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San Mateo, California, United States, 94401
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Stockton, California, United States, 95207
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Colorado
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Centennial, Colorado, United States, 80112
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Colorado Springs, Colorado, United States, 80907
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Florida
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Kissimmee, Florida, United States, 34741
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Miami, Florida, United States, 33173
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Panama City, Florida, United States, 32405
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Georgia
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30033
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Woodstock, Georgia, United States, 30188
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Idaho
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Twin Falls, Idaho, United States, 83301
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Illinois
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Normal, Illinois, United States, 61761
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Indiana
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Indianapolis, Indiana, United States, 46208
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Lafayette, Indiana, United States, 47904
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Kansas
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Overland Park, Kansas, United States, 66210
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Maryland
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Baltimore, Maryland, United States, 21236
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Massachusetts
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Brockton, Massachusetts, United States, 02301
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Michigan
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Bay City, Michigan, United States, 48706
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Novi, Michigan, United States, 48375
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Ypsilanti, Michigan, United States, 48197
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Minnesota
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Minneapolis, Minnesota, United States, 55402
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Plymouth, Minnesota, United States, 55441
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Missouri
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Chesterfield, Missouri, United States, 63017
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Saint Louis, Missouri, United States, 63141
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St Louis, Missouri, United States, 63141
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Montana
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Missoula, Montana, United States, 59808
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Nebraska
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Omaha, Nebraska, United States, 68130
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New Jersey
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Brick, New Jersey, United States, 08724
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Edison, New Jersey, United States, 08820
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Ocean, New Jersey, United States, 07712
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Teaneck, New Jersey, United States, 07666
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Verona, New Jersey, United States, 07044
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New York
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North Syracuse, New York, United States, 13212
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Ohio
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Canton, Ohio, United States, 44718
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Centerville, Ohio, United States, 45458
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Cincinnati, Ohio, United States, 45242
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Toledo, Ohio, United States, 43617
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
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Tulsa, Oklahoma, United States, 74136
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Oregon
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Medford, Oregon, United States, 97504
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Pennsylvania
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Altoona, Pennsylvania, United States, 16601
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Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburg, Pennsylvania, United States, PA
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Pittsburgh, Pennsylvania, United States, 15241
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Sellersville, Pennsylvania, United States, 18960
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South Carolina
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Columbia, South Carolina, United States, 29201
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Greenville, South Carolina, United States, 29615
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Texas
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Austin, Texas, United States, 78759
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Austin, Texas, United States, 78750
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Boerne, Texas, United States, 78006
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El Paso, Texas, United States, 79903
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Houston, Texas, United States, 77030
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Sugar Land, Texas, United States, 77479
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Utah
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Murray, Utah, United States, 84107
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Virginia
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Fairfax, Virginia, United States, 22030
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Washington
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Spokane, Washington, United States, 99204
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Wisconsin
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Madison, Wisconsin, United States, 53715
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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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: placebo
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subcutaneous dose every 4 weeks
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EXPERIMENTAL: lebrikizumab - highest dose
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subcutaneous dose every 4 weeks
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EXPERIMENTAL: lebrikizumab - lowest dose
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subcutaneous dose every 4 weeks
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EXPERIMENTAL: lebrikizumab - middle dose
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subcutaneous dose every 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Rate of asthma exacerbations during the 52-week placebo-controlled period
Time Frame: weeks 0-52
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weeks 0-52
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change in lung function: pre-bronchodilator FEV1
Time Frame: from baseline to week 52
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from baseline to week 52
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Time to first asthma exacerbation
Time Frame: from baseline to week 52
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from baseline to week 52
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Change in fractional exhaled nitric oxide (FeNO)
Time Frame: from baseline to week 52
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from baseline to week 52
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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
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from baseline to week 52
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Change in asthma rescue medication use
Time Frame: from baseline to week 52
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from baseline to week 52
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Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Time Frame: from baseline to week 52
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from baseline to week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
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)
July 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)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GB27864
- 2011-004205-24 (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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