Status:
COMPLETED
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
Lead Sponsor:
MedImmune LLC
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 as...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Body mass index (BMI) between 16-40 kilogram per square meter (kg/m\^2) at Visit 1
- Uncontrolled severe asthma
- A chest x-ray with no abnormality
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
- Non-sterilized males or sterilized males who are less than or equal to (=\<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception
Exclusion
- 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
- Pregnant or breastfeeding women
- Any other respiratory disease
- Previously taken tralokinumab (the study drug)
- Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
- Known immune deficiency
- History of cancer
- Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
- Any disease which may cause complications whilst taking the study drug.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT01402986
Start Date
August 1 2011
End Date
February 1 2014
Last Update
April 4 2017
Active Locations (89)
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1
Research Site
Rancho Mirage, California, United States
2
Research Site
Centennial, Colorado, United States
3
Research Site
New Haven, Connecticut, United States
4
Research Site
Cocoa, Florida, United States