Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT00234741|
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: STA-5326 mesylate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|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|
|Study Start Date :||November 2005|
- 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.
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): NCT00234741
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter Mannon, MD||National Institute of Allergy and Infectious Diseases (NIAID)|