Status:
COMPLETED
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 po...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00138840
Start Date
August 1 2005
Last Update
December 4 2008
Active Locations (35)
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1
Gastroenterology Associates
Little Rock, Arkansas, United States, 72205
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Community Clinical Trials
Orange, California, United States, 92868
4
Medical Associates Research Group
San Diego, California, United States, 92123