Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.

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

Details

• Lead Sponsor: Facet Biotech
• Treatments: Antibodies; Antibodies, Monoclonal; Daclizumab

Criteria

• Moderate to severe active ulcerative colitis diagnosed for at least 4 months.

• Mayo score of 5-10 (inclusive)

• Not used any investigational therapy for 30 days prior to screening

• No treatment with monoclonal antibody therapy within 12 weeks of screening

• No prior treatment with daclizumab