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

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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.


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
3333 Burnet Avenue # Mlc3008
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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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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1 University of New Mexico
Albuquerque, New Mexico 87131
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Ann Arbor, Michigan 48109
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13123 East 16th Avenue
Aurora, Colorado 80045
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5430 Campbell Boulevard
Baltimore, Maryland 21236
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3015 Squalicum Parkway
Bellingham, Washington 98225
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Bend, Oregon 97701
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Boerne, Texas 78006
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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3685 Pueyrredón
Buenos Aires, B1650CVK
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Centennial, Colorado 80112
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Colorado Springs, Colorado 80907
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Columbus, Georgia 31904
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10470 Vista Del Sol Drive
El Paso, Texas 79925
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Fairfax, Virginia 22031
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Florence, Kentucky 41042
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705 Riley Hospital Drive
Indianapolis, Indiana 46202
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Lake Oswego, Oregon 97035
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Los Angeles, California 90027
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2550 Sandy Plains Road
Marietta, Georgia 30066
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Miami, Florida 33165
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Mission Viejo, California 92691
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18 North 3rd Avenue
New Jersey, New Jersey 08904
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35 East 35th Street
New York, New York 10016
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North Logan, Utah 84341
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100 West Gore Street
Orlando, Florida 32806
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Redwood City, California 94063
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6615 Valley Hi Drive
Sacramento, California 95823
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1465 South Grand Boulevard
Saint Louis, Missouri 63104
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San Antonio, Texas 78251
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10447 Texas 151
San Antonio, Texas 78251
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Sarasota, Florida 34233
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325 Tamarack Lane
Shiloh, Illinois 62269
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463 Ashley Ridge Boulevard
Shreveport, Louisiana 71106
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Stockton, California 95207
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1065 Southern Boulevard
The Bronx, New York 10459
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Toledo, OH
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Tucson, Arizona 85716
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