NCT00307827

Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Visilizumab	Visilizumab administered intravenously once per day for two days

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-03-28
• Last updated: 2012-04-27

Locations

16 sites across 6 countries: United States, Canada, Croatia, Italy, Russia, Spain