Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis

The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.

What is visilizumab?

Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis.

Who can participate in this study?

The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics:

* 16-70 year olds * A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry * Active disease despite ongoing treatment with steroids

How is this study conducted?

Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

How does one get more information?

This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email [email protected] or visit www.IBDtrials.com.

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Key information

Conditions

Severe Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Inflammatory Bowel Disease Center, Los Angeles, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

16 -70 year olds
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
Active disease despite ongoing treatment with IV steroids

Treatment and study plan

Visilizumab

Drug

Primary outcomes

Evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that is resistant to intravenous steroids

Sponsors and collaborators

Lead sponsor

Facet Biotech

Industry

Collaborators

PDL BioPharma, Inc.

Registry information

Official study title

A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Dec 20, 2005
Registry last updated: Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting