Ulcerative Colitis
Conditions
Keywords
Colitis, Gastrointestinal Disease, Digestive System Disease, Intestinal Disease, Colonic Disease
Brief summary
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Detailed description
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.
Interventions
DRUGVisilizumab
Sponsors
Facet Biotech
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry. 2. Active disease despite ongoing treatment with steroids
Countries
United States
Outcome results
None listed