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This is a multi-center trial in the US and Europe to test the safety, efficacy and tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a specific protein, called ICAM-1, a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis. The ISIS 2302-CS27 study will compare four dosing regimens and determine the minimum effective dose of alicaforsen enema in UC patients over six weeks as compared to a placebo enema. (The probability of receiving active formulation is 4:1). The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must meet the following criteria at screening to be eligible for enrollment:
Age greater than or equal to 18 years
Diagnosis of left-sided ulcerative colitis of at least 6 months duration
Current left-sided flare, defined as activity in the colon 5-50 cm from the anal verge, extending at least 15 cm proximal to the anal verge and confirmed by endoscopic evaluation within 14 days of baseline visit.
Baseline DAI score of 4-10 including abnormal endoscopic score
On at least one or more of the following treatments for ulcerative colitis prior to baseline visit:
Written informed consent prior to performing screening evaluations.
Exclusion Criteria
Patients who meet any of the following criteria at screening are not eligible for enrollment:
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Data sourced from clinicaltrials.gov
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