A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:March 2012
End Date:July 2013

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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
assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains
uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller
medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment
with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo 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. The anticipated time on study treatment is
up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study
drug for all patients.


Inclusion Criteria:

- Adult patients, 18 to 75 years of age at Visit 1

- Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)

- Bronchodilator response during screening

- Pre-bronchodilator FEV1 40%-80% of predicted during screening

- On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or
equivalent for >/= 6 months prior to the start of screening (Visit 1) with no
anticipated changes throughout the study

- On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within
the prescribed dosing range)

- Uncontrolled asthma as defined by protocol both during screening period and at time
of randomization

- Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to
screening or chest X-ray during screening period confirming the absence of other lung
disease

- Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

- History of severe allergic or anaphylactic reaction to a biologic agent or known
hypersensitivity to any component of the lebrikizumab injection

- Use of zileuton or roflumilast within 6 months prior to screening

- Maintenance oral corticosteroid therapy, defined as daily or alternate day oral
corticosteroid maintenance therapy within the 3 months prior to Visit 1

- Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within
the 4 weeks prior to Visit 1

- Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral
antibiotics within 2 weeks prior to Visit 1

- Active parasitic infection within the 6 months prior to Visit 1

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

- Known immunodeficiency, including, but not limited to, HIV infection

- Evidence of acute or chronic hepatitis or known liver cirrhosis

- History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other
clinically significant lung disease other than asthma

- Known malignancy or current evaluation for a potential malignancy

- Current smoker or former smoker with a history >10 pack years

- History of alcohol, drug or chemical abuse

- Initiation or change in allergen immunotherapy within 3 months prior to Visit 1

- Use of biologic therapy including omalizumab during 6 months prior to Visit 1

- Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1

- Pregnant or lactating women

- Body mass index (BMI) > 38 kg/m2

- Body weight < 40 kg
We found this trial at
63
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1149
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Kissimmee, FL
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1055
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Altoona, PA
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832
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Bay City, MI
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552
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Boerne, TX
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1280
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Brick, NJ
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8348
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Brisbane,
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1445
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Brockton, MA
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900
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Canton, OH
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402
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Centennial, CO
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747
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Centerville, OH
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399
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Chesterfield, MO
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726
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Cincinnati, OH
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Colorado Springs, Colorado 80910
383
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972
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Columbia, SC
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811
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Columbus, GA
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805
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Decatur, GA
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1266
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Edison, NJ
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641
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El Paso, TX
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1114
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Fairfax, VA
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Greenville, South Carolina 29605
882
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Greenville, SC
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1147
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Hershey, PA
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569
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Houston, TX
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643
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Indianapolis, IN
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614
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Lafayette, IN
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1171
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Long Beach, CA
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1168
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Los Angeles, CA
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574
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Madison, WI
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1355
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Medford, OR
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1320
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Miami, FL
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552
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Minneapolis, MN
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1035
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Missoula, MT
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778
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Murray, UT
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510
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Normal, IL
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1195
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North Syracuse, NY
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824
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Novi, MI
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1285
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Ocean, NJ
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158
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Oklahoma City, OK
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262
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Omaha, NE
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1154
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Orange, CA
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190
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Overland Park, KS
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730
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Oxford, AL
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871
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Panama City, FL
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1225
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Philadelphia, PA
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Pittsburg, PA
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550
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Plymouth, MN
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1334
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Redwood City, CA
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418
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Saint Louis, MO
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1335
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San Mateo, CA
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Sellersville, Pennsylvania 18960
1217
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Sellersville, PA
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Spokane, WA
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418
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575
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Sugar Land, TX
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Teaneck, NJ
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805
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Toledo, OH
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Twin Falls, ID
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1274
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Verona, NJ
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Woodstock, GA
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Ypsilanti, MI
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