Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00138840

Run by

Synta Pharmaceuticals Corp.

People needed

282

Starts

2005-08-01

Last updated by the study team

2008-12-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Gastroenterology Associates — Little Rock, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Community Clinical Trials — Orange, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Southern Clinical Research Consultants — Hollywood, Florida, United States
• Borland Groover Clinic — Jacksonville, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Advanced Gastroenterology Highland Lakes Medical Center — Palm Harbor, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology — Atlanta, Georgia, United States
• Univ. of Louisville Clinical Research Unit — Louisville, Kentucky, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Maryland Digestive Disease Research — Laurel, Maryland, United States
• Capital Gastroenterology Consultants, P.A. — Silver Spring, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• St. Louis Center for Clinical Research — St Louis, Missouri, United States
• Gastroenterology Research Associates — Cedar Knolls, New Jersey, United States
• Asher Kornbluth, MD — New York, New York, United States
• Rochester Institute for Digestive Diseases and Sciences, Inc. — Rochester, New York, United States
• Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
• Carolina Digestive Health Associates — Charlotte, North Carolina, United States
• Pinehurst Medical Clinic — Pinehurst, North Carolina, United States
• Wake Research Associates, LLC. — Raleigh, North Carolina, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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