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 |
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.
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
sites
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