Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048113
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:
Ionis Pharmaceuticals, Inc.

Brief Summary:
ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Alicaforsen Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease
Study Start Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age >/= 12 years
  2. Weight >/= 36 kg
  3. CDAI score of 220 - 400
  4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years
  5. No TNF-α inhibitor treatment for three months prior to first study drug infusion

Exclusion Criteria

  1. Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
  2. Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
  3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
  4. Malignancy within 3 years or poorly controlled medical illness
  5. Requires intravenous heparin therapy or with a history of a bleeding problem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048113


Locations
Layout table for location information
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Orange, California, United States
San Diego, California, United States
United States, Colorado
Arvada, Colorado, United States
United States, Florida
Jacksonville, Florida, United States
Winter Park, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
Mexico, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New York
Buffalo, New York, United States
Rochester, New York, United States
United States, North Carolina
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Hamilton, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Washington
Tacoma, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada
Quebec, Canada
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Additional Information:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00048113    
Other Study ID Numbers: ISIS 2302-CS20
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007
Keywords provided by Ionis Pharmaceuticals, Inc.:
Crohn's
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Alicaforsen
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs