MLN0002 in Moderate to Severe Crohn's Disease - 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 Crohn's Disease
IRAS ID
7170
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Eudract number
2008-002783-33
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, Crohn's Disease (CD) and Ulcerative Colitis (UC). 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 but in the case of CD only drug therapy can keep the symptoms 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 C13007 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 C13007 will focus on patients with CD.Approximately 1059 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/H1102/65
Date of REC Opinion
20 Jul 2009
REC opinion
Further Information Favourable Opinion