Safety & tolerability of KRP in Ulcerative Colitis

• Research type

  Research Study

• Full title

  A multicentre, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis.

• IRAS ID

  63370

• Contact name

  James Warburton

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-019970-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ulcerative colitis (UC) is a common disease which causes inflammation and ulceration of the large intestine (colon), leading to abdominal pains, fevers and bloody diarrhoea. The cause of the disease is unknown, but there is strong evidence of dysfunction of the immune system. The main treatment used is 5-amino salicylic acid (5-ASA) compoun's, which reduce local inflammation in the colon. Many patients however, require further treatment with immunosuppressant therapies, such as steroids and azathioprine. In ulcerative colitis, affected parts of the colon have high levels of white blood cells (lymphocytes), which are believed to increase inflammation and ulceration. KRP203 is a drug which blocks sphingosine 1-phosphate receptors, which are presenton the lymphocytes. Sphingosine 1-phosphate is a chemical messenger which binds to lymphocytes and encourages them to move to sites of inflammation. The administration of KRP203 should stop lymphocytes from building up in the affected colon and reduce inflammation. It is therefore hoped that KRP203 may be an alternative treatment in UC. The purpose of the study is to assess if KRP203 is an effective treatment for UC. The study population will consist of approximately 72 (15 of which will be in the UK), male and female patients with clinically active UC who have responded inadequately to conventional therapy with oral 5-ASA. Participants will receive either daily oral treatment with KRP203 or placebo for 8 weeks with regular study visits to assess response to treatment.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/96

• Date of REC Opinion

  1 Feb 2011

• REC opinion

  Further Information Favourable Opinion