A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2012
End Date:June 2017
Contact:Please reference Study ID Number: GB27862 www.roche.com/about_roche/roche_worldwide.htm
Email:genentechclinicaltrials@druginfo.com
Phone:888-662-6728 (U.S. Only)

Use our guide to learn which trials are right for you!

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy 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 screeing 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 druing 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
29
sites
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
302
mi
from 43215
Ashville, NC
Click here to add this to my saved trials
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
522
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
362
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
749
mi
from 43215
Daytona Beach, FL
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
1751
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
4501
mi
from 43215
Honolulu, HI
Click here to add this to my saved trials
715
mi
from 43215
Lewiston, ME
Click here to add this to my saved trials
797
mi
from 43215
Metairie, LA
Click here to add this to my saved trials
335
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
624
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
288
mi
from 43215
Park Ridge, IL
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
2091
mi
from 43215
Santa Clara, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
627
mi
from 43215
St. Joseph, MO
Click here to add this to my saved trials
615
mi
from 43215
Warwick, RI
Click here to add this to my saved trials