NCT00234741

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: Synta Pharmaceuticals Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	STA-5326 mesylate

Timeline

• Start date: 2005-11-01
• First posted: 2005-10-07
• Last updated: 2008-12-04

Locations

1 site across 1 country: United States