Tralokinumab in patients with severe asthma

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma

• IRAS ID

  82577

• Sponsor organisation

  AstraZeneca UK

• Eudract number

  011-001360-21

• ISRCTN Number

  none

• Clinicaltrials.gov Identifier

  tbc

• Research summary

  Asthma is a lung disease associated with inflammation (swelling) of the air passages. Asthma patients may suffer from asthma exacerbations, which is a worsening of asthma symptoms such as shortness of breath, wheezing and chest tightness. During an exacerbation the lining of the airways become swollen and inflamed. Certain chemicals made by the body, called interleukins, are thought to be important in causing inflammation. One of these chemicals, Interleukin-1? (IL-13), appears to play a major role in asthma. Tralokinumab is an antibody made in the laboratory that has been made to block the effect of IL-13. Tralokinumab given as an injection under the skin may help decrease inflammation in the air passages of people with asthma and reduce asthma exacerbations. This study will explore how often tralokinumab should be given, which people respond best, how well tralokinumab is tolerated, the levels of tralokinumab in the body, and changes in the size of air passages of subjects. There will be about 390 people in the study in 16 different countries with about 140 sites. The planned length of time of the study including follow-up is about 79 weeks; 5 weeks for screening, 50 weeks of treatment and 24 weeks follow-up. Subjects will visit the clinic about 33 times. Subjects will be randomised to receive active drug (tralokinumab) or placebo (dummy drug) in a 2:1 ratio. Depending on which cohort subjects are randomised to, they will receive 16 or 26 doses of study drug.Subjects must be aged between 18 to 75 years old with uncontrolled severe asthma and a history of 2 but no more than 6 exacerbations in the past 12 months.All visits will occur at the hospital. Subjects will also be required to complete questionnaires and a lung measurement on an electronic device each day from home.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0270

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion