Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234741
Status:
COMPLETED
Last Update Posted:
2008-12-04
First Post:
2005-10-05
Brief Title:
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohns Disease
Sponsor:
Synta Pharmaceuticals Corp
Organization:
Synta Pharmaceuticals Corp
Study Overview
Official Title:
A Randomized Double-Blind Pilot Study of the Oral IL-1223 Inhibitor STA-5326 Mesylate to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Crohns 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 Crohns 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
This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe active Crohns 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None