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.

This study has been completed.
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00063830
First received: July 7, 2003
Last updated: October 15, 2007
Last verified: October 2007

July 7, 2003
October 15, 2007
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Complete list of historical versions of study NCT00063830 on ClinicalTrials.gov Archive Site
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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.
ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis

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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Interventional
Phase 2
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Alicaforsen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063830
ISIS 2302-CS27
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Isis Pharmaceuticals
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Isis Pharmaceuticals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP