A3921063 CP-690,550 in patients with Ulcerative Colitis

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, parallel group, multi-center study to investigate the safety and efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis

• Contact name

  C Probert

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2008-004564-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This clinical study is being conducted by Pfizer Ltd to determine the efficacy and safety of an immunosuppressant drug, called CP-690,550, in subjects with moderate to severe ulcerative colitis. Ulcerative colitis is a chronic, relapsing inflammatory disease of the large bowel which is characterised by impaired inflammatory response generated against the body's own cells. CP-690,550 seeks to block this impaired inflammatory response. The unmet medical need in patients with ulcerative colitis, expected efficacy of CP-690,550 in this indication and the safety profile of the compound which emerges from phase 2 programs in rheumatoid arthritis and other indications suggests that CP-690,550 has novel anti-inflammatory mechanism of action which is justified in ulcerative colitis. The benefits to the subjects participating in this study will be a potential control of the disease activity by improving symptoms (stool frequency, rectal bleeding, abdominal pain) and general well-being. All subjects may also benefit from gaining knowledge about their health status through study tests and physician assessments, as well as having close monitoring of their inflammatory bowel disease. This is a phase 2, double-blind, placebo-controlled, parallel-group, multi-centre study. 192 subjects who qualify for the study will be randomly assigned to either active drug or placebo (a placebo is a pill that does not contain any drug). Subjects will have an 80% chance of getting active drug. Subjects will be required to take study treatment orally twice a day for 8 weeks. A baseline visit will occur within 7-14 days of screening visit. The double-blind treatment period will last 8 weeks. All subjects will be followed for 4 weeks after completion of study treatment or early withdrawal from the study.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  08/H0606/102

• Date of REC Opinion

  13 Nov 2008

• REC opinion

  Further Information Favourable Opinion