Asthma
Conditions
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.
Interventions
DRUGlebrikizumab
subcutaneous dose every 4 weeks
DRUGplacebo
subcutaneous dose every 4 weeks
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of asthma exacerbations during the 52-week placebo-controlled period | weeks 0-52 |
Secondary
| Measure | Time frame |
|---|---|
| Time to first asthma exacerbation | from baseline to week 52 |
| Change in fractional exhaled nitric oxide (FeNO) | from baseline to week 52 |
| Change in lung function: pre-bronchodilator FEV1 | from baseline to week 52 |
| Change in asthma rescue medication use | from baseline to week 52 |
| Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period | 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 |
Countries
Australia, United States
Outcome results
None listed