Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids
1 other identifier
interventional
144
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2004
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 16, 2005
CompletedFirst Posted
Study publicly available on registry
December 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 9, 2012
March 1, 2012
2.9 years
December 16, 2005
March 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Facet Biotechlead
- PDL BioPharma, Inc.collaborator
Study Sites (11)
Inflammatory Bowel Disease Center
Los Angeles, California, 90048, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Weill Medical College of Cornell
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Related Publications (1)
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.
PMID: 19714757DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2005
First Posted
December 20, 2005
Study Start
January 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
March 9, 2012
Record last verified: 2012-03