Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
