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

Crohn's Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease

Clinical Trial 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 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, 4 treatment period visits over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment. Subjects may continue treatment for an additional 4 weeks of open label STA-5326 mesylate administration that includes an additional 2 treatment period visits. Subjects will undergo a colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at the end of the 4 week open label phase.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00234741
Study type Interventional
Source Synta Pharmaceuticals Corp.
Contact
Status Completed
Phase Phase 2
Start date November 2005
View Details
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