Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Synta Pharmaceuticals Corp.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)