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

July 17, 2009 updated by: Facet Biotech

A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B3000
        • Universitair Ziekenhuis Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Science Center
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • California
      • Anaheim, California, United States, 92801
        • Advanced Medical Research Institute
      • Los Angeles, California, United States, 90035
        • Research Foundation of America
      • Los Angeles, California, United States, 90048
        • Cedar Sinai Medical Center
      • Los Angeles, California, United States, 90045
        • Western Gastroenterology Group
    • Florida
      • Gainesville, Florida, United States, 32608
        • GVAMC
      • Hollywood, Florida, United States, 33021
        • Clinical Research Associates
      • Jacksonville, Florida, United States, 32256
        • Physician Office
      • North Miami Beach, Florida, United States, 33162
        • Mount Sinai Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Drug Research Services, Inc.
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Medlantic Investigators Network
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • Lake Success, New York, United States, 11042
        • New York Center for Clinical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44195-0001
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Gastro Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology Group, P.C.
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research
    • Vermont
      • S. Burlington, Vermont, United States, 05041
        • Fletcher Allen Health Care
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC
      • Richmond, Virginia, United States, 23230
        • Richmond GI Research Group
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53207
        • Wisconsin Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Facet Biotech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

November 14, 2003

First Submitted That Met QC Criteria

November 17, 2003

First Posted (Estimate)

November 18, 2003

Study Record Updates

Last Update Posted (Estimate)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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