GSK2646264 clinical study in healthy subjects and urticaria patients.

• Research type

  Research Study

• Full title

  A randomised double blind (sponsor unblinded), single and repeat ascending dose First Time in Human study in healthy subjects, cold urticaria and chronic spontaneous urticaria subjects to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of topically applied GSK2646264

• IRAS ID

  177983

• Contact name

  HIRA SAJJAD

• Contact email

  hira.sajjad@parexel.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2014-001015-39

• Clinicaltrials.gov Identifier

  NCT02424799

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  GlaxoSmithKline (GSK) is developing the study drug as a potential treatment for chronic urticaria. The illness is characterised by daily or almost daily skin reactions consisting of itchy weals (hives). In chronic urticaria, a molecule found in certain cells of the body, called Spleen Tyrosine Kinase (SYK in short), is thought to be involved in the development of these weals, by releasing histamine and other chemicals involved in inflammation. The study drug is designed to block SYK from working. This may, in turn, reduce the itch, size and duration of the weals. The study drug is administered as a cream.
  This research study is divided into Part A, Part B and Part C. Separate groups of people are included in each part of the study. Approximately 46 people will take part in the entire study. Seventeen (17) healthy volunteers have completed Part A of the study. Part B is intended to include 12 people with cold urticaria (a disease where people get weals in response to cold) and Part C is intended to include 16 people with chronic spontaneous urticaria (a condition lasting for more than 6 weeks in which weals appear without any obvious trigger).

  In the UK, participants will be invited to take part in Part C of the study only. The purpose of Part C is to find out what effects, good or bad, it has in men and women who are between 18 and 70 years old, who have chronic spontaneous urticaria. The study also aims to find out how much of the study drug gets into the blood stream and how long the body takes to get rid of it. The expected participation in this study will last up to 6 weeks from the first screening visit to the final follow-up visit.

• REC name

  HSC REC B

• REC reference

  16/NI/0129

• Date of REC Opinion

  18 Jul 2016

• REC opinion

  Favourable Opinion