Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT00138840|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: STA-5326 mesylate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease|
|Study Start Date :||August 2005|
- Proportion of patients achieving clinical remission and clinical response at Day 29
- Proportion of patients achieving: a clinical remission at Days 29 and 43
- a clinical response from Baseline to Day 29 and from Baseline to Day 43
- a reduction in endoscopic scores from Baseline to Day 29
- an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
- a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138840
|OverallOfficial:||Bruce Sands, MD||Massachusetts General Hospital|