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
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