None listed
Conditions
Interventions
Prefilled siringe and vial. Subcutaneous (SC)
I.Lebrikizumab and Placebo: 52 week placebo-controlled period, patients will receive one of two doses of lebrikizumab (125 mg or 37.5 mg) or placebo, a
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: •Able and willing to provide written informed consent and to comply with the study protocol •Age 18–75 years old at Visit 1 •Asthma diagnosis for >=12 months prior to Visit 1 •Bronchodilator response at Visit 1, 2, or 3 •Pre-bronchodilator FEV1 of 40%–80% predicted at both Visits 2 and 3 •On ICS therapy at a total daily dose of 500–2000 ug of fluticasone propionate 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 (LABA, LTRA, LAMA, 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 (except for theophylline dose, which may be adjusted on the basis of theophylline levels) •Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3 •Chest X-ray or computed tomography (CT) scan within 3 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.Adherence is defined as patients responding affirmatively that they have taken their asthma controller therapy >= 70% of days during the screening.
Exclusion criteria
Exclusion criteria: •History of a severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to any component of the lebrikizumab injection•Maintenance oral, systemic or intra-articular corticosteroid therapy•Infection•Active tuberculosis•Known immunodeficiency•Evidence of acute or chronic hepatitis or known liver cirrhosis•AST,ALT,or total bilirubin elevation•Clinically significant abnormality on screening ECG or laboratory tests•History of interstitial lung disease, chronic obstructive pulmonary disease, or other significant lung disease •Known malignancy or evaluation for a potential malignancy•Other significant medical disease that is uncontrolled•History of alcohol or drug abuse•Current smoker, former smoker with smoking history of >10 pack-years,or unwilling to abstain from smoking•Past and/or current use of any anti–IL13 or anti–IL4/IL13 therapy•Use of a licensed or investigational monoclonal antibody other than anti–IL13 or anti IL4/IL13•Use of an immunomodulatory or immunosuppressive therapy•Use of other investigational therapy not described•Use of zileuton or roflumilast•Use of traditional Chinese herbal medicine•Initiation of or change in allergen immunotherapy•Receipt of a live attenuated vaccine•Female patients of reproductive potential who are unwilling to use a method of contraception for the duration of the study Pregnant or lactating•Body mass index >38 kg/m2•Body weight <40 kg•History of bronchial thermoplasty*More information,see the protocol
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Palma
PPD Peru S.A.C.
Outcome results
None listed