Phase II Study of RR110 in Patients With Active Crohn's Disease

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R&R Inc.

Criteria

Inclusion Criteria:

• Patients with CDAI score ranging from 220 to 450

• Patients with CRP > 1 mg/dL

• Patients who can be hospitalized at least 2 weeks after first administration

Exclusion Criteria:

• Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening

• Patients who have had surgical bowel resections within 4 weeks of screening

• Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening