A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
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
2 other identifiers
interventional
205
2 countries
63
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 P50-P75 for phase_2 asthma
Started Mar 2012
63 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
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1.3 years
March 1, 2012
November 1, 2016
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 (63)
Unknown Facility
Oxford, Alabama, 36203-7190, United States
Unknown Facility
Long Beach, California, 90808, United States
Unknown Facility
Los Angeles, California, 90025, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Redwood City, California, 94063, United States
Unknown Facility
San Mateo, California, 94401, United States
Unknown Facility
Stockton, California, 95207, United States
Unknown Facility
Centennial, Colorado, 80112, United States
Unknown Facility
Colorado Springs, Colorado, 80907, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Panama City, Florida, 32405, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Woodstock, Georgia, 30188, United States
Unknown Facility
Twin Falls, Idaho, 83301, United States
Unknown Facility
Normal, Illinois, 61761, United States
Unknown Facility
Indianapolis, Indiana, 46208, United States
Unknown Facility
Lafayette, Indiana, 47904, United States
Unknown Facility
Overland Park, Kansas, 66210, United States
Unknown Facility
Baltimore, Maryland, 21236, United States
Unknown Facility
Brockton, Massachusetts, 02301, United States
Unknown Facility
Bay City, Michigan, 48706, United States
Unknown Facility
Novi, Michigan, 48375, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
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Minneapolis, Minnesota, 55402, United States
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Plymouth, Minnesota, 55441, United States
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Chesterfield, Missouri, 63017, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59808, United States
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Omaha, Nebraska, 68130, United States
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Brick, New Jersey, 08724, United States
Unknown Facility
Edison, New Jersey, 08820, United States
Unknown Facility
Ocean City, New Jersey, 07712, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Verona, New Jersey, 07044, United States
Unknown Facility
North Syracuse, New York, 13212, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Centerville, Ohio, 45458, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
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Toledo, Ohio, 43617, United States
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Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
Unknown Facility
Altoona, Pennsylvania, 16601, United States
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Hershey, Pennsylvania, 17033, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Pittsburgh, Pennsylvania, PA, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Austin, Texas, 78750, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
Boerne, Texas, 78006, United States
Unknown Facility
El Paso, Texas, 79903, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Sugar Land, Texas, 77479, United States
Unknown Facility
Murray, Utah, 84107, United States
Unknown Facility
Fairfax, Virginia, 22030, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Madison, Wisconsin, 53715, United States
Unknown Facility
Brisbane, Queensland, 4075, 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
July 1, 2013
Study Completion
July 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11