A Phase 2 Study With AMG 853 in Asthma

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects with Inadequately Controlled Asthma

• IRAS ID

  38984

• Contact name

  Anthony Frew

• Sponsor organisation

  Amgen Inc

• Eudract number

  2009-013538-26

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Amgen Inc. has discovered a new molecule called AMG 853 that has been designed to block a naturally occurring substance in the body called CRTH2 that is believed to be involved in asthma. Amgen Inc. is doing this research study to evaluate the safety of AMG 853 taken by mouth twice a day and to see if the research participants' asthma improves. This information will be used by Amgen Inc. to further develop AMG 853 for the treatment of asthma and possibly other medical conditions. Another purpose of this study is to see how much AMG 853 is in the blood after this is taken by the research participant. It will also answer the questions of what the body does to AMG 853 and how AMG 853 may affect the body. Participants also will be asked to provide samples of their blood. These samples may be studied to look for special markers that may help researchers develop tests that can be used to tailor the use of AMG 853 in treating inflammatory diseases (e.g. asthma) and/or for studying inflammatory diseases. Participation may last up to 20 weeks. This includes a screening period of up to 2 weeks, a run-in period of 4 weeks, and a treatment period of 12 weeks. After the treatment period of the study, there will be a 2 week follow-up period.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/18

• Date of REC Opinion

  7 Apr 2010

• REC opinion

  Further Information Favourable Opinion