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

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: Visilizumab

• Registration Number: NCT00307827
• Lead Sponsor: Abbott

Brief 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.

Study Timeline

• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-28
• Study Start: 2006-04
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Visilizumab	Visilizumab middle dose level
Arm 3	Visilizumab	Visilizumab high dose level
Arm 1	Visilizumab	Visilizumab low dose level

Primary Outcome Measures

Name	Time	Method
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).	Day 45

Secondary Outcome Measures

Name	Time	Method
Comparison of subjects in the three visilizumab dose groups	During the course of the study

Trial Locations

Locations (16)

Site Reference ID/Investigator# 71896; 🇺🇸 Cleveland, Ohio, United States

Site Reference ID/Investigator# 72338; 🇭🇷 Osijek, Croatia

Site Reference ID/Investigator# 72334; 🇭🇷 Zagreb, Croatia

Site Reference ID/Investigator# 71875; 🇨🇦 Hamilton, Canada

Site Reference ID/Investigator# 71895; 🇺🇸 Chapel Hill, North Carolina, United States

Site Reference ID/Investigator# 72315; 🇷🇺 St. Petersburg, Russian Federation

Site Reference ID/Investigator# 72342; 🇷🇺 St. Petersburg, Russian Federation

Site Reference ID/Investigator# 72368; 🇪🇸 Badalona - Barcelona, Spain

Site Reference ID/Investigator# 72366; 🇪🇸 Majadahonda (Madrid), Spain

Site Reference ID/Investigator# 71894; 🇺🇸 Savannah, Georgia, United States

Site Reference ID/Investigator# 72314; 🇷🇺 Moscow, Russian Federation

Site Reference ID/Investigator# 71953; 🇷🇺 Nizhny-Novgorod, Russian Federation

Site Reference ID/Investigator# 72345; 🇮🇹 Bologna, Italy

Site Reference ID/Investigator# 71873; 🇨🇦 Winnipeg, Canada

Site Reference ID/Investigator# 71897; 🇺🇸 Worcester, Massachusetts, United States

Site Reference ID/Investigator# 71913; 🇺🇸 Manhasset, New York, United States