Effect of 150, 300 or 600mg CAT-354/Placebo on Asthma (V08/Dec/2008)

• Research type

  Research Study

• Full title

  A Phase 2a, Randomised, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma.

• IRAS ID

  15387

• Sponsor organisation

  MedImmune Ltd

• Eudract number

  2008-007844-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Asthma is a complex inflammatory disease characterised by airway hyperresponsiveness (AHR) in association with airway inflammation. This study will examine the effect of three injected doses of CAT-354 versus placebo on the control of asthma in adults with uncontrolled, moderate-to-severe, persistent asthma. CAT-354 is an antibody that binds to a molecule called Interleukin-1? (IL-13) preventing it from working. As IL-13 is thought to be important in the persistence of asthma, it is hypothesised that CAT-354 will improve asthma control.The level of control of asthma is assessed by a questionnaire and any change in control will be established by analysis of the results from the questionnaires throughout the study. In addition for each subject, the number of asthma attacks, the use of asthma control medication, changes in breathing tests, adverse events experienced and blood and sputum samples to see how much drug is present will be examined.The study will enrol 192 subjects, at around 20 sites in Europe, ensuring 144 evaluable subjects complete the study. Subjects will be male and female, aged 18 to 55 years of age, with uncontrolled, moderate-to-severe, persistent asthma. Once enrolled, subjects will be allocated one of three doses of CAT-354 or placebo. A placebo drug is a dummy form of the active study drug. Subjects are able to take any medication for asthma control throughout the study including current medications they are on. The subject will participate in the study for 24 weeks from study day 1, which will involve 14 visits to the clinic. CAT-354 will be given subcutaneously (injected beneath the skin) every 2 weeks for the first 12 weeks. Subjects will undergo the following at some or all of the visits: blood, urine and sputum sampling, blood pressure, heart rate, temperature, respiration rate, examination by the doctor, breathing tests, and questionnaires.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/28

• Date of REC Opinion

  1 Apr 2009

• REC opinion

  Further Information Favourable Opinion