A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - 17 |
Updated: | 5/17/2017 |
Start Date: | August 31, 2013 |
End Date: | December 28, 2016 |
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants
with asthma whose disease remains uncontrolled despite daily treatment with inhaled
corticosteroids (ICS) therapy and at least one second controller medication. Participants
will be randomized in a 1:1:1 ratio to receive double-blind treatment with either
lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks
(Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by
an optional 52-week double-blind active-treatment extension. The anticipated time on study
treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue
prematurely or decide not to take part in the optional active-treatment extension will
transition to the 20-week safety follow-up period.
evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants
with asthma whose disease remains uncontrolled despite daily treatment with inhaled
corticosteroids (ICS) therapy and at least one second controller medication. Participants
will be randomized in a 1:1:1 ratio to receive double-blind treatment with either
lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks
(Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by
an optional 52-week double-blind active-treatment extension. The anticipated time on study
treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue
prematurely or decide not to take part in the optional active-treatment extension will
transition to the 20-week safety follow-up period.
Inclusion Criteria:
- Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response during screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
- On high dose 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
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 prior to Visit 1
- Treatment with systemic (oral, intravenous [IV], or intramuscular [IM])
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, human immunodeficiency virus
(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 greater than (>) 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy,
including lebrikizumab
- Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5
drug half-lives (whichever is longer) prior to Visit 1
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or
during screening
- History of bronchial thermoplasty
We found this trial at
44
sites
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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705 Riley Hospital Drive
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1465 South Grand Boulevard
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
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