A phase 2b safety and efficacy study of BMS 945429 in Crohn's disease
Research type
Research Study
Full title
A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose- Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease
IRAS ID
101638
Contact name
Andrew Robinson
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2011-004763-72
Clinicaltrials.gov Identifier
Research summary
Current medications for Crohn's disease have been shown to be effective in treating acute inflammation but additional treatment options are also needed for maintaining remission and long term use. This clinical trial will be looking at a new study treatment called BMS 945429, which is an antibody that is designed to target cells that have been associated with Crohn's disease. BMS-945429 may help block a protein called interleukin-6 which is important in chronic swelling and may be responsible for the signs and symptoms of diseases such as Crohn??s disease. This trial will assess the safety, effectiveness and the way the drug is absorbed, acts and is excreted from the body. This study includes a Screening, induction, maintenance, open label and follow up period. The Induction and Maintenance Periods are blinded which means, except in an emergency, neither the subject, nor the study doctor will know the treatment assignment. Subjects will be assigned to either BMS -945429 or a placebo treatment group. In the Open Label Period, subjects will receive the active drug (BMS-945429). Subjects are then followed up for 6 months at the end of treatment. Participating patients will undergo: physical examinations, multiple blood, urine and stool tests, a heart function test, 2 MRE tests which is a special kind of MRI that captures images of the stomach and intestines. They will also be required to complete a daily diary of their Crohns disease symptoms whilst in the study. Globally the study will begin in May 2012 and approximately 288 patients will participate world wide. In the UK the study will begin in September 2012 and is due to end in March 2014. The study is funded by Bristol Myers Squibb.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
12/EM/0279
Date of REC Opinion
13 Sep 2012
REC opinion
Further Information Favourable Opinion