NCT00063414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2005

Completed
Last Updated

December 5, 2022

Status Verified

October 1, 2007

Enrollment Period

2.3 years

First QC Date

June 25, 2003

Last Update Submit

December 1, 2022

Conditions

Ulcerative Colitis

Interventions

AlicaforsenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Chicago, Illinois, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

alicaforsen

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2003

First Posted

June 27, 2003

Study Start

November 20, 2002

Primary Completion

March 24, 2005

Study Completion

March 24, 2005

Last Updated

December 5, 2022

Record last verified: 2007-10

Locations

US(1)