Asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: lebrikizumab
Product Code: RO5490255/F01-01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LEBRIKIZUMAB
Current Sponsor code: RO5490255
Other descriptive name: TNX-650,
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adolescent patients, 12 - 17 years of age at the time of screening and randomization • Asthma diagnosis for >/= 12 months at Visit 1 • Bronchodilator response during screening • Pre-bronchodilator FEV1 of 40% - 90% predicted at both Visits 2 and 3 • On high dose inhaled corticosteroid (ICS) therapy for >/= 6 months prior to Visit 1 • On an eligible second controller medication for 6 months prior to Visit 1 • Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization • Demonstrated adherence with controller medication during the screening period. Are the trial subjects under 18? yes Number of subjects for this age range: 375 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection • Maintenance oral corticosteroid therapy within 3 months of Visit 1 • Treatment with systemic (oral, intravenous, or intramuscular) corticosteroids within 4 weeks prior to Visit 1 or during the screening period • Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study • Infection that meets the following criteria: - Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening: - Any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; - Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; - Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening; • History of active tuberculosis requiring treatment • Known immunodeficiency, including, but not limited to, HIV infection • Evidence of acute or chronic hepatitis or known liver cirrhosis • History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma • Diagnosis or history of malignancy or current evaluation for potential malignancy • Current smoker or former smoker with a history of > 10 pack-years • History of alcohol or drug abuse • Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months prior to Visit 1 • Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lebrikizumab compared with placebo as measured by the rate of asthma exacerbations To evaluate the efficacy and safety of different dose levels of lebrikizumab compared with placebo ;Secondary Objective: To evaluate change in pre-bronchodilator FEV1, time to first asthma exacerbation, change in FeNO, change in patient-reported asthma-specific health related quality of life, change in asthma rescue medication use, and rate of urgent asthma-related health care utilization during the placebo-controlled period To evaluate the acceptability (perceived pain) of injections of lebrikizumab ;Primary end point(s): Rate of asthma exacerbations during the 52-week placebo-controlled period;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. from baseline to week 52 2. week 52 3 to 5. from baseline to week 52 6. 52 weeks 7. 124 weeks;Secondary end point(s): 1. Relative change in pre-bronchodilator FEV1 (liters) 2. Time to first asthma exacerbation 3. Change in fractional exhaled nitric oxide (FeNO) 4. Change in asthma-specific, health-related quality of life: overall score of the Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) 5. Change in asthma rescue medication use 6. Rate of urgent asthma-related health care utilization 7. Safety: incidence of adverse events. | — |
Countries
Argentina, Brazil, Canada, Colombia, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Peru, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed