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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2004 by Ionis Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00048295
First Posted: October 30, 2002
Last Update Posted: June 24, 2005
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.
Information provided by:
Ionis Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
Crohn's Disease Drug: Alicaforsen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: ISIS 2302-CS21, 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

Resource links provided by NLM:


Further study details as provided by Ionis Pharmaceuticals, Inc.:

Estimated Enrollment: 150
Study Start Date: May 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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): NCT00048295


Locations
Belgium
Kortrijk, Belgium
Roeselare, Belgium
Czech Republic
Hradic Kralove 2, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Praha, Czech Republic
Usti nad Orlici, Czech Republic
Germany
Minden, Germany
Munster, Germany
Italy
Torino, Italy
Poland
Krakow, Poland
Szczecin, Poland
Warszawa, Poland
Wroclaw, Poland
Spain
Barcelona, Spain
Valencia, Spain
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00048295     History of Changes
Other Study ID Numbers: ISIS 2302-CS21
First Submitted: October 29, 2002
First Posted: October 30, 2002
Last Update Posted: June 24, 2005
Last Verified: April 2004

Additional relevant 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