Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Treatments:
Alicaforsen
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