Ulcerative ColitisPhase 2NCT00073047
Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
A Phase 2 study testing Daclizumab in people with Ulcerative Colitis and Gastrointestinal Disease, run by Facet Biotech at 35 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ulcerative Colitis, Gastrointestinal Disease, Inflammatory Bowel Disease
- What is being tested?
- Daclizumab
- How many people
- 150 participants
- Where
- 35 sitesin 3 countries
- Study dates
- Apr 2003to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- 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
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
United States30 sites
Advanced Medical Research Institute
Anaheim, California, 92801
Medlantic Investigators Network
Annapolis, Maryland, 21401
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
University of North Carolina
Chapel Hill, North Carolina, 27514
The University of Chicago Hospital
Chicago, Illinois, 60637
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
Columbia Gastro Associates
Columbia, South Carolina, 29203
GVAMC
Gainesville, Florida, 32608
Long Island Clinical Research Associates
Great Neck, New York, 11021
Clinical Research Associates
Hollywood, Florida, 33021
Clinical Research Associates
Huntsville, Alabama, 35801
Physician Office
Jacksonville, Florida, 32256
New York Center for Clinical Research
Lake Success, New York, 11042
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Research Foundation of America
Los Angeles, California, 90035
Western Gastroenterology Group
Los Angeles, California, 90045
Cedar Sinai Medical Center
Los Angeles, California, 90048
Memphis Gastroenterology Group, P.C.
Memphis, Tennessee, 38120
Drug Research Services, Inc.
Metairie, Louisiana, 70001
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
Nashville Medical Research
Nashville, Tennessee, 37205
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Mount Sinai Medical Center
North Miami Beach, Florida, 33162
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Richmond GI Research Group
Richmond, Virginia, 23230
McGuire DVAMC
Richmond, Virginia, 23249
Fletcher Allen Health Care
South Burlington, Vermont, 05041
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Canada4 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
London Health Science Center
London, Ontario, N6A 5A5
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
About this study
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
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.
- Being tested
- Daclizumab
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal, Humanized Monoclonal antibody
- Medical subject headings
- Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2003 (estimated)
- Study startApr 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073047
- Sponsor's protocol ID
- 1008
- Status last verified
- Jul 2009
- First submitted
- 14 Nov 2003
- Last updated
- 20 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00073047
- Acronym / sponsor ID
- 1008
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal, Humanized Monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 18 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2009.
- Crohn's and Colitis Foundation of AmericaLink provided by the sponsor.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daclizumab in people with Ulcerative Colitis and Gastrointestinal Disease, run by Facet Biotech at 35 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2009.