A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma
NCT ID: NCT02099656
Last Updated: 2017-09-06
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
64 participants
INTERVENTIONAL
2014-11-06
2016-10-13
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
Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab on Days 1 and 8, and on Weeks 4 and 8.
Lebrikizumab
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Inhaled corticposteroids (ICS)
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Second Asthma Controller Medication
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Placebo
Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab matching placebo on Days 1 and 8, and on Weeks 4 and 8.
Placebo
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Inhaled corticposteroids (ICS)
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Second Asthma Controller Medication
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Interventions
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Lebrikizumab
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Placebo
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Inhaled corticposteroids (ICS)
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Second Asthma Controller Medication
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening
* Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
* On ICS therapy at a total daily dose of 500-2000 mcg of fluticasone propionate dry powder inhaler (DPI) or equivalent for \>/= 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
* On an eligible second controller medication (long-acting Beta-agonist \[LABA), leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonists \[LAMAs\] or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
* Uncontrolled asthma at Visit 1 and/or 2 and at Visit 3
* Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) that confirms the absence of other clinically significant lung disease
* Demonstrated adherence with controller medication during the screening period
Exclusion Criteria
* Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
* Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic treatment or any respiratory infection within 4 weeks prior to Visit 1 or during screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to Visit 1 or during screening, or any parasitic infection within 6 months prior to Visit 1 or during screening
* Active tuberculosis requiring treatment within 12 months prior to Visit 1
* Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
* History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
* Known current malignancy or current evaluation for a potential malignancy
* Unable to safely undergo elective flexible fiberoptic bronchoscopy
* Clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the participant's ability to participate in the study, or to impact the study assessments
* History of alcohol or drug abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
* Current smoker or history of smoking (greater than \[\>\] 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
* Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
* Use of a licensed or investigational monoclonal antibody other than anti-IL-13, or anti IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Initiation of or increase in allergen immunotherapy within 3 months prior to Visit 1 or during screening
* Body mass index \>38 kilograms per square meter (kg/m\^2)
* Body weight \<40 kilograms (kg)
* History of bronchial thermoplasty
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Arizona
Tucson, Arizona, United States
LAC-USC Medical Center
Los Angeles, California, United States
University of California Davis Health System; Division of Pulmonary and Critical Care Medicine
Sacramento, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics; Internal Medicine
Iowa City, Iowa, United States
Brigham and Women's Hospital; Pulmonary Division
Boston, Massachusetts, United States
Washington University; Pediatrics
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center; Gastroenterology & Digestive Health
Winston-Salem, North Carolina, United States
Pen Memory Center
Philadelphia, Pennsylvania, United States
Temple University Hospital ; Lung Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
UTMB Pathology Clinical Services
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital-SCC/WCM
Edmonton, Alberta, Canada
VGH Research Pavilion
Vancouver, British Columbia, Canada
McMaster University Health Sciences Center
Hamilton, Ontario, Canada
Hôpital Arnaud de Villeneuve
Montpellier, , France
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, , France
Connolly Hospital
Dublin, , Ireland
Skånes Universitetssjukhus, Lund
Lund, , Sweden
Queen's University Belfast; NICRN Respiratory Research Office
Belfast, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
St Mary's Hospital
London, , United Kingdom
The Medicines Evaluation Unit
Manchester, , United Kingdom
Countries
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References
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Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4.
Other Identifiers
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2014-000275-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB29260
Identifier Type: -
Identifier Source: org_study_id
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