Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18-75 years old at study start
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
You may not be if
Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
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
Clareo Health | A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
