Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Colitis
+7

+ Colitis, Ulcerative
+ Colonic Diseases
Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2003
See protocol details

Summary

Principal SponsorFacet Biotech
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis 
NCT00073047
Principal SponsorFacet Biotech
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colitis
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Ulcer
Inflammatory Bowel Diseases
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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 35 locations
Suspended
Clinical Research AssociatesHuntsville, United StatesSee the location
Suspended
Advanced Medical Research InstituteAnaheim, United States
Suspended
Research Foundation of AmericaLos Angeles, United States
Suspended
Western Gastroenterology GroupLos Angeles, United States
Completed35 Study Centers