Status:
COMPLETED
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Lead Sponsor:
Synta Pharmaceuticals Corp.
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
STA-5326 is an oral 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...
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 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 subject 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 :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00234741
Start Date
November 1 2005
Last Update
December 4 2008
Active Locations (1)
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1
Nih/Niaid
Bethesda, Maryland, United States, 20892