Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synta Pharmaceuticals Corp.
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 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.