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

Primary Purpose

Ulcerative Colitis, Gastrointestinal Disease, Inflammatory Bowel Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daclizumab
Sponsored by
Facet Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal, Humanized Monoclonal antibody

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Associates
  • Advanced Medical Research Institute
  • Research Foundation of America
  • Western Gastroenterology Group
  • Cedar Sinai Medical Center
  • GVAMC
  • Clinical Research Associates
  • Physician Office
  • Mount Sinai Medical Center
  • Atlanta Gastroenterology Associates
  • The University of Chicago Hospital
  • University of Kentucky Chandler Medical Center
  • Drug Research Services, Inc.
  • Medlantic Investigators Network
  • St. Louis Center for Clinical Research
  • Long Island Clinical Research Associates
  • New York Center for Clinical Research
  • University of North Carolina
  • Consultants for Clinical Research
  • Cleveland Clinic Foundation
  • Oklahoma Foundation for Digestive Research
  • University of Pittsburgh Medical Center
  • Columbia Gastro Associates
  • Memphis Gastroenterology Group, P.C.
  • Nashville Medical Research
  • Fletcher Allen Health Care
  • Digestive and Liver Disease Specialists
  • Richmond GI Research Group
  • McGuire DVAMC
  • Wisconsin Center for Advanced Research
  • Universitair Ziekenhuis Gasthuisberg
  • University of Alberta
  • Vancouver General Hospital
  • London Health Science Center
  • Montreal General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 14, 2003
Last Updated
July 17, 2009
Sponsor
Facet Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00073047
Brief Title
Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Facet Biotech

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Gastrointestinal Disease, Inflammatory Bowel Disease
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal, Humanized Monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Daclizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Advanced Medical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Foundation of America
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Western Gastroenterology Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Cedar Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GVAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Clinical Research Associates
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Physician Office
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Mount Sinai Medical Center
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Drug Research Services, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Medlantic Investigators Network
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Columbia Gastro Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Memphis Gastroenterology Group, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Fletcher Allen Health Care
City
S. Burlington
State/Province
Vermont
ZIP/Postal Code
05041
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Richmond GI Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53207
Country
United States
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
ZIP/Postal Code
B3000
Country
Belgium
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.ccfa.org
Description
Crohn's and Colitis Foundation of America

Learn more about this trial

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

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