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

This study has been completed.
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00048113
First received: October 24, 2002
Last updated: October 15, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

Estimated Enrollment: 150
Study Start Date: September 2001
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048113

  Show 30 Study Locations
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00048113     History of Changes
Other Study ID Numbers: ISIS 2302-CS20
Study First Received: October 24, 2002
Last Updated: October 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Isis Pharmaceuticals:
Crohn's

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Alicaforsen
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014