isis 2302-cs22, a 6-week, active-controlled clinical study to evaluate the effectiveness of alicaforsen (isis 2302) in patients with mild to moderate active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a multi-center trial 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-cs22 study will examine the effects of one of two dosages of alicaforsen delivered by enema over a six-week period as compared to an active control, mesalamine enema (the probability of receiving the alicaforsen formulation is 2:1). the primary objective of this study is to evaluate the percentage reduction in dai at week 6.


Eligibility 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 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: 1. stable background oral mesalamine therapy for greater than or equal to 30 days, and/or 2. stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or 3. stable azathiprine therapy for greater than or equal to 60 days prior to baseline * 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: * bowel stricture, toxic megacolon, colonic dysplasia, adenoma or carcinoma * uncontrolled hematologic, renal, hepatic, metabolic, psychiatric, cns, pulmonary or cardiovascular disease, or sufficient level of disease that could interfere with the patient's ability to comply with protocol participation * enteric pathogens or presence of clostridium difficile toxin in stool * history of colon resection * major surgical procedure within one month of baseline visit * steroid or mesalamine enema within 14 days of baseline visit * systemic steroids (including acth) within 30 days of baseline visit * tumor necrosis factor-alpha (tnf-α) inhibitor treatment within 90 days of baseline visit * non-steroidal anti-inflammatory agents (nsaids), including cyclooxygenase-2 (cox-2) inhibitors, within 14 days of baseline visit * methotrexate, cyclosporin or thalidomide within 90 days of baseline visit * any active infection currently requiring treatment * malignancy within 5 years except for squamous cell or basal cell cancers of the skin * current infectious, ischemic, or immunological disease with gastrointestinal involvement * isis 2302 treatment within 12 months of baseline visit * history of allergy to mesalamine * treatment with an investigational or off-label drug within 90 days of screening or currently in long-term follow up for another investigational treatment protocol