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. - Full Text View

Sponsor:	Isis Pharmaceuticals
Information provided by:	Isis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00063830

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Alicaforsen	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: ISIS 2302

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063830

Locations

United States, California

Sacramento, California, United States

Sponsors and Collaborators

Isis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	ISIS 2302-CS27
Study First Received:	July 7, 2003
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00063830 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Isis Pharmaceuticals:

Ulcerative Colitis

Additional relevant MeSH terms:

Immunologic Factors
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Gastrointestinal Agents
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Immunosuppressive Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
ISIS 2302
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on November 30, 2009