Asthma
Conditions
Keywords
Adult Asthma
Brief summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).
Interventions
Subcutaneous repeating dose
DRUGplacebo
Subcutaneous repeating dose
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Body weight 40 kg--150 kg * Chest radiograph with no evidence of clinically significant abnormality * Uncontrolled asthma
Exclusion criteria
* Asthma exacerbation during screening * Known malignancy * Known immunodeficiency * Pre-existing lung disease other than asthma * Uncontrolled clinically significant medical disease * Current smoker * History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator * Prior allergic reaction to a monoclonal antibody * Patients (men and women) of reproductive potential who are not willing to use contraception * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume in 1 second (FEV1) | From baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in rescue medication use | From baseline to Week 1 |
| Change in pre-bronchodilator FEV1 | From baseline to Week 24 |
| Change in quality of life and symptom scores | From baseline to Week 12 |
| Rate of asthma exacerbations | During the 24 week treatment period |
| Frequency and severity of adverse events | Through study completion or early study discontinuation |
| Incidence of human anti-therapeutic antibodies (ATA) | At the end of the follow-up period |
| Change in peak flow | From baseline to Week 1 |
Outcome results
None listed