Ulcerative Colitis
Conditions
Keywords
Intravenous, Steroid-Refractory, Ulcerative Colitis
Brief summary
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Detailed description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Interventions
DRUGvisilizumab
Sponsors
PDL BioPharma, Inc.
Facet Biotech
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
* Males and females, 18 years of age or older. * Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent. * Severe active disease, as defined by a Modified Truelove & Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 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. * Negative Clostridium difficile test. * Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
Exclusion criteria
* UC requiring immediate intervention or toxic megacolon requiring imminent 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 of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent. * 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-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α 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
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Netherlands, Norway, Slovakia, Ukraine, United States
Outcome results
None listed