Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|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|
- To measure the changes from predose in peripheral blood and mucosal cytokines in subjects with active CD after administration of STA-5326 mesylate or placebo for 4 weeks
- To measure changes in other immunologic parameters.
- To explore the level of cell-surface markers and specific gene expression patterns.
- To measure changes in laboratory surrogate efficacy markers.
- To measure the proportion of subjects in clinical remission at Day 29.
- To measure the proportion of subjects with a clinical response at Day 29.
- To measure the proportion of subjects with both clinical remission and clinical response at Day 29.
- To confirm STA-5326 mesylate (and metabolite) levels in blood following oral administration to CD patients.
- To measure the changes in endoscopic scores from Baseline to Day 29.
- To measure the changes in the Inflammatory Bowel Disease Questionnaire overall score from Baseline to Day 29.
|Study Start Date:||November 2005|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter Mannon, MD||National Institute of Allergy and Infectious Diseases (NIAID)|