a study of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

pdl biopharma, inc. was formerly known as protein design labs, inc.

Eligibility criteria:
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 exclusion criteria above. * unable or willing to discontinue any uc drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-asa, immediately prior to randomization. * nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures. * any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.

Keywords: intravenous, steroid-refractory, ulcerative colitis