Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Isis Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00048295
First received: October 29, 2002
Last updated: June 23, 2005
Last verified: April 2004
  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-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 Isis Pharmaceuticals:

Estimated Enrollment: 150
Study Start Date: May 2002
  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: 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
Isis Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00048295     History of Changes
Other Study ID Numbers: ISIS 2302-CS21
Study First Received: October 29, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014