NCT00032305

Research Study in Patients With Severe Ulcerative Colitis

A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Facet Biotech · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Detailed description

A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Visilizumab

Timeline

• Start date: 2002-03-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2002-03-18
• Last updated: 2012-03-07

Locations

7 sites across 1 country: United States