A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:October 2011
End Date:March 2014
Contact:Kwai Poon
Email:clinicaltrialenquiries@medimmune.com
Phone:+44(0)1223 895930

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A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma


The purpose of this study is to determine whether the addition of tralokinumab to standard
asthma medication is effective in the treatment of adults with asthma


Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic
disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in
improved control of asthma. This study will determine whether the addition of tralokinumab
to standard asthma medications results in a reduced rate of asthma exacerbations in
participants with severe asthma

Inclusion Criteria:

1. Age 18-75 years

2. Body mass index (BMI) between 16-40 kg/m2 at Visit 1.

3. Uncontrolled severe asthma

4. A chest x-ray with no abnormality

5. Females of childbearing potential who are sexually active with a nonsterilized male
partner must use highly effective contraception from Day1

6. Nonsterilized males or sterilized males who are ≤ 1 year post-vasectomy who are
sexually active with a female partner of childbearing potential must use a highly
effective method of contraception

Exclusion Criteria:

1. Employee of the clinical study site or any other individuals directly involved with
the conduct of the study, or immediate family members of such individuals.

2. Pregnant or breastfeeding women

3. Any other respiratory disease

4. Previously taken tralokinumab (the study drug)

5. Current smoker or a history of smoking which would be more than 1 pack per day for 10
years

6. Known immune deficiency

7. History of cancer

8. Hepatitis B, C or HIV

9. Any disease which may cause complications whilst taking the study drug
We found this trial at
19
sites
1422
mi
from 91732
Des Moines, IA
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
356
mi
from 91732
San Francisco, CA
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2356
mi
from 91732
Allentown, PA
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2008
mi
from 91732
Anderson, SC
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1259
mi
from 91732
Bismarck, ND
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Boys Town, Nebraska 68010
1291
mi
from 91732
Boys Town, NE
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2436
mi
from 91732
Bronx, NY
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Charleston, South Carolina 29407
2180
mi
from 91732
Charleston, SC
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817
mi
from 91732
Denver, CO
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1728
mi
from 91732
Evanston, IL
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2315
mi
from 91732
Fort Lauderdale, FL
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1174
mi
from 91732
Grand Island, NE
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1357
mi
from 91732
Houston, TX
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822
mi
from 91732
Lake Oswego, OR
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Los Angeles, California 90025
13
mi
from 91732
Los Angeles, CA
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2486
mi
from 91732
New Haven, CT
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Rockville Centre, New York 11570
2451
mi
from 91732
Rockville Centre, NY
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105
mi
from 91732
San Diego, CA
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101
mi
from 91732
San Diego, CA
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