A Study of Lebrikizumab in Participants With Uncontrolled Asthma 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 as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of
the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5
milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 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 at 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 microgram (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 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
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Abingdon, Virginia 24210
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Albany, Georgia 31707
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1 University of New Mexico
Albuquerque, New Mexico 87131
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Asheville, North Carolina 28801
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5508 Parkcrest Drive
Austin, Texas 78756
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Birmingham, Alabama 35209
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660 Glades Road
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35 North Pearl Street
Brockton, Mississippi 02301
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Centerville, Ohio 45458
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1570 Woodlake Drive
Chesterfield, Missouri 63017
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Colorado Springs, Colorado 80907
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Colorado Springs, Colorado 80907
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10910 Little Patuxent Parkway
Columbia, Maryland 21044
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Columbia, South Carolina 29201
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Dallas, Texas 75230
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1400 Jackson St
Denver, Colorado 80206
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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1740 Oak Tree Road
Edison, New Jersey 08820
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2121 Wyoming Avenue
El Paso, Texas 79903
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Granada Hills, California 91344
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Greenville, South Carolina 29615
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30 Pointe Circle
Greenville, South Carolina 29615
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500 University Dr
Hershey, Pennsylvania 17033
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Honolulu, Hawaii 96814
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6501 Fannin Street
Houston, Texas 77030
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259 1st St
Mineola, New York 11501
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333 Cedar St
New Haven, Connecticut 06504
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North Dartmouth, Massachusetts 02747
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1111 North Lee Avenue
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2000 North Mays Street
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100 Stoneforest Drive
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