Crohn's Disease Clinical Trial
Official title:
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.
This is a multi-centre, randomised, double-blind, placebo-controlled, parallel group study to
evaluate the efficacy of two oral doses of GSK1605786A (500 mg once daily, 500 mg twice
daily) as compared to placebo in the induction of clinical response over a 12-week treatment
period in subjects with moderately-to-severely active Crohn's disease. Secondary objectives
will include assessment of the safety and evaluation of the efficacy in induction of
remission.
The study is planned to randomise approximately 600 subjects (200 subjects/group) with active
Crohn's disease, diagnosed for at least 4 months with a documented history of disease in the
small and/or large intestine, and characterised by a Crohn's Disease Activity Index (CDAI)
score between 220 to and 450, inclusive. Subjects must have reported an inadequate response
or intolerance to Crohn's disease treatment with corticosteroids or immunosuppressants.
Inclusion of subjects who received prior treatment with a biologic anti-tumour necrosis
factor (TNF) agent will be limited to approximately 50% of the study population. All subjects
are required to have a diagnosis with identification of anatomic location of Crohn's disease,
which has been established by visualisation of the gastrointestinal tract within 12 months of
screening. Subjects who have not had a visualisation of the gastrointestinal tract within 12
months are required to undergo an endoscopic assessment during the screening period. Subjects
will be required to have evidence of current active inflammation at the time of randomisation
either by endoscopy or by inflammatory biomarkers [elevated C-reactive protein (CRP) greater
than the upper limit of normal (ULN) plus a positive faecal calprotectin test]. Subjects who
do not meet the requirements based on inflammatory biomarker test results will be required to
qualify based on endoscopic assessment during screening. Subjects will be allowed to
participate in the study while continuing on stable doses of agents typically used to treat
Crohn's disease. Following the screening period, subjects will be randomised at baseline to
receive blinded treatment with one of two doses of GSK1605786A (500 mg once daily or twice
daily) or placebo for 12 weeks. Response and remission endpoints, using the CDAI, will be
evaluated at Weeks 4, 8 and 12.
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