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

Study Overview
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Brief Summary
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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).

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

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Visilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Visilizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity. |  |  |