Severe Ulcerative Colitis Clinical Trial
Official title:
A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids
| Verified date | March 2012 |
| Source | Facet Biotech |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | December 2006 |
| Est. primary completion date | December 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | Inflammatory Bowel Disease Center | Los Angeles | California |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | Weill Medical College of Cornell | New York | New York |
| United States | UPHS/Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | University of California, San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Facet Biotech | PDL BioPharma, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03907631 -
Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)
|