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

Facet Biotech

Status and phase

Completed

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Visilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00267722

291-412

Details and patient eligibility

About

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).

Full description

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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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