Clinical trial NCT00267306: Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
Official title: A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Severe Ulcerative Colitis
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
Collaborators: name: PDL BioPharma, Inc.
First posted: 2005-12-20
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.

What is visilizumab?

Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis.

Who can participate in this study?

The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics:

* 16-70 year olds
* A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
* Active disease despite ongoing treatment with steroids

How is this study conducted?

Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

How does one get more information?

This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.

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

Eligibility criteria: Inclusion Criteria:

* 16 -70 year olds
* A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
* Active disease despite ongoing treatment with IV steroids

Primary outcomes:
measure: Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Inflammatory Bowel Disease Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: UPHS/Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
References:
citation: Baumgart DC, Targan SR, Dignass AU, Mayer L, van Assche G, Hommes DW, Hanauer SB, Mahadevan U, Reinisch W, Plevy SE, Salzberg BA, Buchman AL, Mechkov GM, Krastev ZA, Lowder JN, Frankel MB, Sandborn WJ. Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitis. Inflamm Bowel Dis. 2010 Apr;16(4):620-9. doi: 10.1002/ibd.21084.