MLN0002 in Moderate to Severe Ulcerative Colitis - Phase III

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

• IRAS ID

  7026

• Sponsor organisation

  Millennium Pharmaceuticals, Inc.

• Eudract number

  2008-002782-32

• ISRCTN Number

  N/A

• Research summary

  MLN0002 is a new drug that has been shown to have a positive effect on patients suffering with the inflammatory bowel diseases, Ulcerative Colitis (UC) and Crohn's Disease (CD). Both diseases result in the inflammation of sections of the gastrointestinal tract which gives rise to some unpleasant and painful symptoms including constant diarrhoea, abdominal pain, weight loss and sometimes more severe effects. The symptoms of both diseases come and go and whilst in some cases of UC the symptoms can go away completely without medical help, in most cases drug treatment is required to keep the symptoms of UC at bay. Current treatments for these diseases have some limitations and it is hoped that MLN0002 will prove to be a more favourable treatment option. Study C13006 is part of a program of studies sponsored by Millennium Pharmaceuticals, Inc. that will review the effectiveness and safety of MLN0002 in a larger group of patients, study C13006 will focus on patients with Ulcerative Colitis. Approximately 826 patients will be enrolled in this study where the first phase of the study (Induction Phase) will look at whether MLN0002 can induce a favourable clinical response within 6 weeks. The second phase (Maintenance Phase)of the study will look at if receiving MLN0002 regularly over a further 44 weeks will keep the disease in remission. The safety of MLN0002 when given to a more widespread group of patients will also be evaluated. Treatment options vary within the two phases of the study and also depend on at what timepoint during the study a patient is enrolled. However patients will either receive placebo or MLN0002 via an intravenous infusion on a regular basis throughout the study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/66

• Date of REC Opinion

  20 Jul 2009

• REC opinion

  Further Information Favourable Opinion