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Completed

NCT Number: NCT00048295

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kortrijk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Alicaforsen

Drug

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2002
First posted
Oct 30, 2002
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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