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Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073047
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : July 20, 2009
Information provided by:
Facet Biotech

Brief Summary:
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Gastrointestinal Disease Inflammatory Bowel Disease Drug: Daclizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis
Study Start Date : April 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Moderate to severe active ulcerative colitis diagnosed for at least 4 months.
  • Mayo score of 5-10 (inclusive)
  • Not used any investigational therapy for 30 days prior to screening
  • No treatment with monoclonal antibody therapy within 12 weeks of screening
  • No prior treatment with daclizumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073047

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Sponsors and Collaborators
Facet Biotech
Additional Information:
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Responsible Party: Nancy Teasdale, Director, Regulatory Affairs Identifier: NCT00073047    
Other Study ID Numbers: 1008
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009
Keywords provided by Facet Biotech:
Ulcerative Colitis
Inflammatory Bowel Disease
Humanized Monoclonal antibody
Additional relevant MeSH terms:
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Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs