A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese
 Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus
 Long-Acting β2-Agonist
This is a 52-week, open-label, multi-centre study designed to evaluate the safety of
 tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and
 adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid
 plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to
 receive 22 completed.
Inclusion Criteria:

 1. Age 12 - 75 yrs

 2. Documented physician-diagnosed asthma

 3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose
 corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and
 a long-acting beta-2 agonist (LABA)

 4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of
 their Predicted Normal Value (PNV)

 5. Asthma Control Questionnaire-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 of breastfeeding

 5. History or cancer

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

 7. Previous receipt of tralokinumab