The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Visilizumab administered intravenously once per day for two days
Site Reference ID/Investigator# 71894
Savannah, Georgia, United States
Site Reference ID/Investigator# 71897
Worcester, Massachusetts, United States
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).
Time frame: Day 45
Comparison of subjects in the three visilizumab dose groups
Time frame: During the course of the study
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Site Reference ID/Investigator# 71913
Manhasset, New York, United States
Site Reference ID/Investigator# 71895
Chapel Hill, North Carolina, United States
Site Reference ID/Investigator# 71896
Cleveland, Ohio, United States
Site Reference ID/Investigator# 71875
Hamilton, Canada
Site Reference ID/Investigator# 71873
Winnipeg, Canada
Site Reference ID/Investigator# 72338
Osijek, Croatia
Site Reference ID/Investigator# 72334
Zagreb, Croatia
Site Reference ID/Investigator# 72345
Bologna, Italy
...and 6 more locations