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

A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073047

Enrollment

150

Registered

2003-11-18

Start date

2003-04-30

Completion date

2006-07-31

Last updated

2009-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Disease, Inflammatory Bowel Disease, Ulcerative Colitis

Keywords

Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal, Humanized Monoclonal antibody

Brief 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.

Interventions

DRUGDaclizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

Belgium, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026