Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
Public ClinicalTrials.gov record NCT00267306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00267306
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2003
- Primary completion
- Nov 30, 2006
- Completion
- Nov 30, 2006
- Last update posted
- Mar 8, 2012
2004 – 2006
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Inflammatory Bowel Disease Center | Los Angeles | California | 90048 | — |
| University of California, San Francisco | San Francisco | California | 94115 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Weill Medical College of Cornell | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| UPHS/Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00267306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 8, 2012 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00267306 live on ClinicalTrials.gov.