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