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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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alicaforsen
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Stable background oral mesalamine therapy for greater than or equal to 30 days, and/or Stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or 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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 25, 2003
Last Updated
December 1, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00063414
Brief Title
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
Official Title
ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 20, 2002 (Actual)
Primary Completion Date
March 24, 2005 (Actual)
Study Completion Date
March 24, 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alicaforsen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Stable background oral mesalamine therapy for greater than or equal to 30 days, and/or Stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or 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
Facility Information:
City
Chicago
State/Province
Illinois
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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