Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease
1 other identifier
interventional
282
2 countries
35
Brief Summary
STA-5326 is an experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines. This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ 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
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedDecember 4, 2008
December 1, 2008
August 26, 2005
December 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving clinical remission and clinical response at Day 29
Secondary Outcomes (5)
Proportion of patients achieving: a clinical remission at Days 29 and 43
a clinical response from Baseline to Day 29 and from Baseline to Day 43
a reduction in endoscopic scores from Baseline to Day 29
an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein
Interventions
Eligibility Criteria
You may qualify if:
- Is male or female aged 18 through 75 years.
- Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
- Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.
You may not qualify if:
- Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this study.
- Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
- Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
- Has clinically significant hematologic, hepatic or renal laboratory abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Gastroenterology Associates
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Community Clinical Trials
Orange, California, 92868, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Southern Clinical Research Consultants
Hollywood, Florida, 33021, United States
Borland Groover Clinic
Jacksonville, Florida, 32204, United States
Miami Research Associates
Miami, Florida, 33173, United States
Advanced Gastroenterology Highland Lakes Medical Center
Palm Harbor, Florida, 34684, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology
Atlanta, Georgia, 30342, United States
Univ. of Louisville Clinical Research Unit
Louisville, Kentucky, 40202, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Maryland Digestive Disease Research
Laurel, Maryland, 20707, United States
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, 20901, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927, United States
Asher Kornbluth, MD
New York, New York, 10128, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, 14607, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374, United States
Wake Research Associates, LLC.
Raleigh, North Carolina, 27612, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Columbia Gastroenterology Associates, P.A.
Columbia, South Carolina, 29203, United States
Gastroenterology Center of the MidSouth
Germantown, Tennessee, 38138, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
University of Calgary Health Sciences
Calgary, Alberta, T2N4N1, Canada
London Health Science Center South Street Campus
London, Ontario, N6A 4G5, Canada
London Health Science Center University Campus
London, Ontario, N6A 5A5, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, S7K1N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
Bruce Sands, MD
Massachusetts General Hospital
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
August 26, 2005
First Posted
August 30, 2005
Study Start
August 1, 2005
Last Updated
December 4, 2008
Record last verified: 2008-12