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Completed

NCT Number: NCT00267722

Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's disease. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site up to 17 months. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).

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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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inflammatory Bowel Disease Center, Los Angeles, California, United States

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About this study

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-70 years old
  • Diagnosis of moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's disease, defined as Crohn's Disease Activity Index greater than or equal to 250, C-reactive protein greater than or equal to upper limit of normal, and endoscopic evidence of moderate-to-severe active inflammatory disease
  • Test negative for Clostridium difficile within 3 weeks
  • Signed informed consent, including permission to use protected health information

Exclusion criteria

  • History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
  • Pregnant or nursing
  • HIV, Hepatitis B or Hepatitis C infection
  • Presence of obstructive symptoms, confirmed by endoscopy
  • Serious infections within 12 months
  • Active infections that require antibiotic therapy
  • Started or changed dose of sulfasalazine, 5-aminosalicylic acid; or antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
  • Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks
  • Increase dose of corticosteroid medication within 2 weeks
  • Received a live vaccine within 6 weeks
  • Received any monoclonal antibodies or investigational agents within 3 months
  • Received cyclosporine or tacrolimus (FK506) within 4 weeks
  • Dose change or discontinuation from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
  • Significant organ dysfunction
  • Likely to require surgery in the next 6 months
  • History of lymphoproliferative disorder
  • History of tuberculosis or mycobacteria infection or positive chest x-ray
  • History of thrombophlebitis or pulmonary embolus
  • History of immune deficiency or autoimmune disorders other than Crohn's
  • History of subtherapeutic blood levels of anticonvulsive medications within 1 week

Treatment and study plan

Visilizumab

Drug

Primary outcomes

  1. Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.

Secondary outcomes

  1. Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.

Sponsors and collaborators

Lead sponsor

Facet Biotech

Industry

Collaborators

  • PDL BioPharma, Inc.

Registry information

Official study title

A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 21, 2005
Registry last updated
Mar 7, 2012

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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