a study of lebrikizumab in patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication (verse)

Conditions: Asthma

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.


Eligibility criteria:
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