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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267722
• Other study ID #: 291-412
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2005
• Last updated: March 6, 2012
• Start date: February 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2012
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Visilizumab

Locations

Country	Name	City	State
United States	Inflammatory Bowel Disease Center	Los Angeles	California
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Facet Biotech	PDL BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.

External Links

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