Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00138840
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-30
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-03
• Last Update Posted: 2008-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Is male or female aged 18 through 75 years.
• Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
• Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.

Exclusion Criteria

• Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this study.
• Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
• Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
• Has clinically significant hematologic, hepatic or renal laboratory abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving clinical remission and clinical response at Day 29

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (35)

Gastroenterology Associates; 🇺🇸 Little Rock, Arkansas, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Community Clinical Trials; 🇺🇸 Orange, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

Southern Clinical Research Consultants; 🇺🇸 Hollywood, Florida, United States

Borland Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Advanced Gastroenterology Highland Lakes Medical Center; 🇺🇸 Palm Harbor, Florida, United States

Shafran Gastroenterology Center; 🇺🇸 Winter Park, Florida, United States

Atlanta Gastroenterology; 🇺🇸 Atlanta, Georgia, United States

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