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	Intervention	Phase
Crohn’s disease	Drug: STA-5326 mesylate	Phase II

Further Study Details: 

Primary Outcomes: Proportion of patients achieving clinical remission and clinical response at Day 29.
Secondary Outcomes: 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
Expected Total Enrollment:  282

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00138840

Arkansas
      Gastroenterology Associates, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Advanced Clinical Research Institute, Anaheim,  California,  92801,  United States; Recruiting
Florida
      Southern Clinical Research Consultants, Hollywood,  Florida,  33021,  United States; Recruiting
      Shafran Gastroenterology Center, Winter Park,  Florida,  32789,  United States; Recruiting
      Miami Research Associates, Miami,  Florida,  33173,  United States; Recruiting
Missouri
      St. Louis Center for Clinical Research, St. Louis,  Missouri,  63128,  United States; Recruiting
New York
      Rochester Institute for Digestive Diseases and Sciences, Inc., Rochester,  New York,  14607,  United States; Recruiting
North Carolina
      Pinehurst Medical Clinic, Pinehurst,  North Carolina,  28374,  United States; Recruiting
      Wake Research Associates, LLC., Raleigh,  North Carolina,  27612,  United States; Recruiting
      Piedmont Medical Research Associates, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Tennessee
      Gastroenterology Center of the MidSouth, German Town,  Tennessee,  38138,  United States; Recruiting
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study chairs or principal investigators

Bruce Sands, MD,  Massachusetts General Hospital   

Study ID Numbers:  5326-07
Last Updated:  August 29, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00138840
Health Authority: United States: Food and Drug Administration; Health Canada; Statni ustav pro kontrolu leciv (Czech Republic); Direction générale Médicaments (Belgium); Agence Française de Sécurité Sanitaire des Produits de Santé (France); National Institute of Pharmacy (Hungary); Ministry of Health (Israel)
ClinicalTrials.gov processed this record on 2005-08-30