A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01402986
- Run by
- MedImmune LLC
- People needed
- 689
- Starts
- 2011-08-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2017-04-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Research Site — Centennial, Colorado, United States
- Research Site — New Haven, Connecticut, United States
- Research Site — Cocoa, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Winter Park, Florida, United States
- Research Site — Albany, Georgia, United States
- Research Site — Fargo, North Dakota, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Upland, Pennsylvania, United States
- Research Site — Killeen, Texas, United States
- Research Site — Buenos Aires, Argentina
- Research Site — Ciudad de Buenos Aires, Argentina
- Research Site — Monte Grande, Argentina
- Research Site — Ranelagh, Argentina
- Research Site — Rosario, Argentina
- Research Site — Calgary, Alberta, Canada
- Research Site — Ottawa, Ontario, Canada
- Research Site — Montreal, Quebec, Canada
- Research Site — Québec, Quebec, Canada
- Research Site — Quillota, Chile
- Research Site — Santiago, Chile
- Research Site — Valparaíso, Chile
- Research Site — Viña del Mar, Chile
- Research Site — Jindřichův Hradec, Czechia
- Research Site — Rancho Mirage, California, United States
Full record on ClinicalTrials.gov
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