ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ionis Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.
