Ulcerative Colitis
Conditions
Keywords
Steroid-Refractory, IVSR-UC, Ulcerative Colitis
Brief summary
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
Detailed description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Interventions
DRUGVisilizumab
Visilizumab administered intravenously once per day for two days
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria: * Males and females, 18 years of age or older. * Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent. * Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) \>= 11 at consent, with a confirmatory MTWSI \>= 10 on or after the fifth consecutive day of intravenous (IV) steroids and within 1 day prior to randomization. * Mayo score \>= 10 and Mayo mucosal subscore \>= 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids. * Adequate contraception from the day of consent through 3 months after the last dose of study drug. * Negative serum pregnancy test at screening. * Negative Clostridium difficile test within 10 days prior to randomization. * Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
Exclusion criteria
Subjects will be ineligible for this study if they meet any one of the following criteria: * UC requiring immediate intervention. * History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis * Presence of ileostomy. * White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin level less than 8 g/dL. * Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months. * Live vaccination within 6 weeks prior to randomization. * Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality. * History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix). * Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV). * Pregnancy or nursing. * Treatment with a first dose of infliximab or another anti-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a drug within 2 weeks of randomization. * Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization. * Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1). | Day 45 |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of subjects in the three visilizumab dose groups | During the course of the study |
Countries
Canada, Croatia, Italy, Russia, Spain, United States
Outcome results
None listed