A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
NCT ID: NCT02104674
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
PHASE3
313 participants
INTERVENTIONAL
2014-06-30
2016-05-31
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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Placebo
placebo
SC injection given on Days 1, 29, and 57
Singulair (montelukast)
montelukast [Singulair]
10 mg given orally once daily for 12 weeks
lebrikizumab
lebrikizumab
Given SC on Days 1, 29, and 57
Interventions
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lebrikizumab
Given SC on Days 1, 29, and 57
montelukast [Singulair]
10 mg given orally once daily for 12 weeks
placebo
SC injection given on Days 1, 29, and 57
Eligibility Criteria
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Inclusion Criteria
* Asthma diagnosis for \>/= 12 months prior to study start
* Bronchodilator response at screening
* Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3
* No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan
* Stable and symptomatic asthma during the screening period
* Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose
Exclusion Criteria
* Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event
* Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start
* Documented prior treatment failure with Montelukast
* Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study
* Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start
* Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
* History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
* History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
* Current or history of smoking (\> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
* Past and/or current use of any anti-IL-13 or anti- IL4/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 study start or during screening
* Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
* Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening
* Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening
* Pregnancy or breast feeding
* Body mass index \> 38 kg/m2
* Body weight \< 40 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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Birmingham, Alabama, United States
Flagstaff, Arizona, United States
Scottsdale, Arizona, United States
Alhambra, California, United States
Anaheim, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Napa, California, United States
Rancho Mirage, California, United States
Redwood City, California, United States
Stockton, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Waterbury, Connecticut, United States
Cooper City, Florida, United States
Kissimmee, Florida, United States
New Port Richey, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Duluth, Georgia, United States
Normal, Illinois, United States
Oak Lawn, Illinois, United States
River Forest, Illinois, United States
Avon, Indiana, United States
Louisville, Kentucky, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Papillion, Nebraska, United States
Ocean City, New Jersey, United States
Rochester, New York, United States
The Bronx, New York, United States
Hendersonville, North Carolina, United States
High Point, North Carolina, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Greer, South Carolina, United States
Boerne, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
Fairfax, Virginia, United States
Henrico, Virginia, United States
Greenfield, Wisconsin, United States
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Florianópolis, Santa Catarina, Brazil
Santo André, São Paulo, Brazil
Santo André, São Paulo, Brazil
Gabrovo, , Bulgaria
Razgrad, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Brampton, Ontario, Canada
Toronto, Ontario, Canada
Jablonec nad Nisou, , Czechia
Jindřichův Hradec, , Czechia
Karlovy Vary - Stará Role, , Czechia
Strakonice, , Czechia
Tbilisi, , Georgia
Auckland, , New Zealand
Auckland, , New Zealand
Beckenham, , New Zealand
Bialystok, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Poznan, , Poland
Tarnów, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Caguas, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Oradea, , Romania
Timișoara, , Romania
Moscow, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yekaterinburg, , Russia
Spišská Nová Ves, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Lyttleton, , South Africa
Parow, , South Africa
Pretoria Gauteng Province, , South Africa
Soweto, , South Africa
Manchester, , United Kingdom
Countries
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References
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Korenblat P, Kerwin E, Leshchenko I, Yen K, Holweg CTJ, Anzures-Cabrera J, Martin C, Putnam WS, Governale L, Olsson J, Matthews JG. Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids. Respir Med. 2018 Jan;134:143-149. doi: 10.1016/j.rmed.2017.12.006. Epub 2017 Dec 13.
Other Identifiers
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WA29249
Identifier Type: -
Identifier Source: org_study_id