Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis
1 other identifier
interventional
150
3 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2003
Typical duration for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 14, 2003
CompletedFirst Posted
Study publicly available on registry
November 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJuly 20, 2009
July 1, 2009
November 14, 2003
July 17, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Facet Biotechlead
Study Sites (35)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Advanced Medical Research Institute
Anaheim, California, 92801, United States
Research Foundation of America
Los Angeles, California, 90035, United States
Western Gastroenterology Group
Los Angeles, California, 90045, United States
Cedar Sinai Medical Center
Los Angeles, California, 90048, United States
GVAMC
Gainesville, Florida, 32608, United States
Clinical Research Associates
Hollywood, Florida, 33021, United States
Physician Office
Jacksonville, Florida, 32256, United States
Mount Sinai Medical Center
North Miami Beach, Florida, 33162, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
The University of Chicago Hospital
Chicago, Illinois, 60637, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Drug Research Services, Inc.
Metairie, Louisiana, 70001, United States
Medlantic Investigators Network
Annapolis, Maryland, 21401, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
New York Center for Clinical Research
Lake Success, New York, 11042, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Columbia Gastro Associates
Columbia, South Carolina, 29203, United States
Memphis Gastroenterology Group, P.C.
Memphis, Tennessee, 38120, United States
Nashville Medical Research
Nashville, Tennessee, 37205, United States
Fletcher Allen Health Care
South Burlington, Vermont, 05041, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Richmond GI Research Group
Richmond, Virginia, 23230, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207, United States
Universitair Ziekenhuis Gasthuisberg
Leuven, B3000, Belgium
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9, Canada
London Health Science Center
London, Ontario, N6A 5A5, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2003
First Posted
November 18, 2003
Study Start
April 1, 2003
Study Completion
July 1, 2006
Last Updated
July 20, 2009
Record last verified: 2009-07