A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATIO
- Conditions
- -J45J45
- Registration Number
- PER-062-13
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 11
1)For patients considered to be minors according to national legislation in each country, the written consent of the parent or legal guardian must be obtained, as well as the assent of the minor according to his or her capacity to understand the information provided. Patients within the specified age range who are not legally considered to be minors according to national legislation must consent in their own right. Patients enrolled as minors who attain legal adulthood during the course of the study must consent in their own right at that time.
2)Able and willing to comply with the study protocol
3)Age 12–17 years old at Visit 1 and Visit 3
4)Asthma diagnosis for ≥ 12 months prior to Visit 1
5)Bronchodilator response at Visits 1, 2, or 3
6)Pre-bronchodilator FEV1 of 40%–90% predicted at both Visits 2 and 3
7)On ICS therapy at a total daily dose of 500-2000 μg of fluticasone propionate DPI or equivalent ≥ 6 months prior to Visit 1 with no changes within 4 weeks prior to Visit 1 and no anticipated changes throughout the study.
8)On an eligible second controller medication (LABAs, LTRAs, LAMAs, or theophylline) for 6 months prior to Visit 1 with no changes within 4 weeks prior to Visit 1 and no anticipated changes throughout the study (except for theophylline dose, which may be adjusted on the basis of theophylline levels)
9)Uncontrolled asthma at Visit 1 and/or 2, and at Visit 3.
10)Demonstrated adherence with controller medication during the screening period.
Patients who meet any of the following criteria will be excluded from study entry:
1)History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
2)Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to Visit 1
3)Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
4)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
5)Infection that meets any of the following criteria:
-Any infection that resulted in hospital admission for ≥ 24 hours within 4 weeks prior to Visit 1 or during screening
-Any infection that required 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
Antibiotics include any antimicrobial therapy used to treat bacterial, fungal, parasitic, viral or other infections. Antibiotics prescribed for prophylaxis should be discussed with the medical monitor
6)History of active tuberculosis requiring treatment
7. Known immunodeficiency, including, but not limited to, HIV infection
8. Evidence of acute or chronic hepatitis or known liver cirrhosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method