A Study of Lebrikizumab in 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:18 - 75
Updated:5/20/2017
Start Date:July 31, 2013
End Date:January 2, 2017

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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease
remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and
at least one second controller medication. Participants will be randomized in 1:1:1 ratio to
receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo,
administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their
standard-of-care therapy. This will be followed by a 52-week double-blind active treatment
extension. During double-blind active treatment extension period, all participants will
receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study
treatment is 104 weeks. After study treatment, all participants will complete a 20-week
safety follow-up.


Inclusion Criteria:

- Asthma diagnosis for greater than equal to (>/=) 12 months prior to Visit 1

- Bronchodilator response at Visit 1, 2, or 3

- Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3

- On ICS therapy at a total daily dose of 500-2000 micrograms (mcg) of fluticasone
propionate dry powder inhaler (DPI) or equivalent for >/=6 months prior to Visit 1

- On an eligible second controller medication (long-acting beta-agonist [LABA],
leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or
theophylline) for 6 months prior to Visit 1

- Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3

- Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or
chest X-ray during the screening period (prior to Visit 3) confirming the absence of
other clinically significant lung disease

- 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 of 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 requiring hospital admission for >/=24 hours or requiring treatment with IV
or IM antibiotics within 4 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 infection that required treatment with oral antibiotics within 2 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

- Active tuberculosis requiring treatment within 12 months prior to Visit 1

- Known immunodeficiency, including, but not limited to, human immunodeficiency virus
(HIV) infection

- Evidence of acute or chronic hepatitis or known liver cirrhosis

- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD),
or other clinically significant lung disease other than asthma

- Known current 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 prior to Visit 1 (whichever is longer) or during screening

- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or
during screening
We found this trial at
70
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2128 W Flagler St # 201
Miami, Florida 33144
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221 East 23rd
Panama City, Florida 32405
850-785-6550
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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Altoona, PA
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Austin, Texas 78745
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3015 Squalicum Parkway
Bellingham, Washington 98225
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Boerne, Texas 78006
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Buenos Aires, C1169
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Centennial, Colorado 80112
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Clearwater, Florida 33765
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Decatur, Georgia 30033
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Deland, Florida 32720
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10470 Vista Del Sol Drive
El Paso, Texas 79925
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1488 Oak Street
Eugene, Oregon 97401
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Fairfax, Virginia 22031
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Flagstaff, Arizona 86001
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Fountain Valley, California 92708
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Grand Rapids, Michigan 49525
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Greenville, South Carolina 29607
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Henrico, Virginia 23233
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High Point, North Carolina 27262
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Houston, Texas 77098
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Iowa City, Iowa 52240
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4000 East Charleston Boulevard
Las Vegas, Nevada 89104
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2 Wake Robin Road
Lincoln, Rhode Island 02865
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3816 Woodruff Avenue
Long Beach, California 90808
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Long Beach, California 90804
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10780 Santa Monica Boulevard
Los Angeles, California 90025
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1950 Sawtelle Boulevard
Los Angeles, California 90025
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Madison, Wisconsin 53715
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Manassas, Virginia 20110
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4833 Medical Center Drive
McKinney, Texas 75069
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Medford, OR
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Michigan City, IN
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Missoula, Montana
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Mount Laurel, New Jersey 08054
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Napa, California 94558
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New Hyde Park, New York 11042
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North Dartmouth, Massachusetts 02747
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1740 Southeast 18th Street
Ocala, Florida 34471
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Ocean City, New Jersey 07712
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Oklahoma City, Oklahoma 73103
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Omaha, Nebraska 68134
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Orange, California 92868
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Papillion, Nebraska 68046
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Pell City, Alabama 35128
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1015 Chestnut Street
Philadelphia, Pennsylvania 19107
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Portland, Oregon 97216
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Rancho Mirage, California 92270
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10330 Old Olive Street Road
Saint Louis, Missouri 63141
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Saint Louis, Missouri 63110
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San Antonio, Texas 78205
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San Diego, California 92108
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San Francisco, California 94143
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Seattle, Washington 98105
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601 Lawn Avenue
Sellersville, Pennsylvania 18960
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Skillman, New Jersey 08558
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Spokane, Washington 99204
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Stockton, California 95207
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The Bronx, New York 10467
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Toledo, Ohio 43617
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Tucson, Arizona 85710
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Waterbury, Connecticut
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Winter Park, Florida 32789
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100 Stoneforest Drive
Woodstock, Georgia 30188
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