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

Facet Biotech

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Disease; Inflammatory Bowel Disease; Ulcerative Colitis

Treatments: Drug: Daclizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00073047

1008

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind