STA-5326 in Crohn's Disease Patients

Synta Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Crohn's Disease

Treatments

Drug: STA-5326

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088062

CDAI Scores of 220-450

5326-03

Crohn's Disease

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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