Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
NCT00138840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 282
Last updated 2008-12-04
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.
Conditions
Interventions
- DRUG
-
STA-5326 mesylate
Sponsors & Collaborators
-
Synta Pharmaceuticals Corp.
lead INDUSTRY
Principal Investigators
-
Bruce Sands, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
Countries
- United States
- Canada
Study Locations
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