A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

This is a randomized, double-blind, parallel group, placebo-controlled study designed to
evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with
uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a
history of asthma exacerbations. Approximately 770 subjects will be randomized globally.
Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at
the study site, over a 52-week treatment period.

Inclusion Criteria:

1. Age 12 -75

2. Documented physician-diagnosed asthma.

3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
fluticasone propionate dry powder formulation equivalents) and a LABA

4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
age) of their PNV.

5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1

6. ACQ-6 score ≥1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma

2. History of anaphylaxis following any biologic therapy

3. Hepatitis B, C or HIV

4. Pregnant or breastfeeding

5. History of cancer

6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years

7. Previous receipt of tralokinumab