Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis
Brief summary
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.
Interventions
DRUGAlicaforsen
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 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 * Patients with pancolitis * 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 * 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
Countries
United States
Outcome results
None listed