STA-5326 in Crohn's Disease Patients

A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.

Inclusion Criteria:

• Patients 18-65 years old
• Crohn's Disease for 6 months
• CDAI scores between 220-450
• +/- 5-ASA, stable dose for > 2 weeks
• +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
• +/- Infliximab with no treatment within 4 weeks
• +/- 6-Mercaptopurine, with a stable dose for 8 weeks
• +/- Antibiotics, with a stable dose for 2 weeks

Exclusion Criteria:

• Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
• Pregnancy, breast feeding
• History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
• Bowel obstruction
• Surgical bowel resection within 90 days
• Total parenteral nutrition (TPN), CYA, tacrolimus