A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
CompletedJune 25, 2009
July 1, 2008
July 13, 2007
June 23, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, 18 years of age or older.
- Diagnosis of UC verified by endoscopy within 60 months prior to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Facet Biotechlead
- PDL BioPharma, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2007
First Posted
July 17, 2007
Last Updated
June 25, 2009
Record last verified: 2008-07