Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
Conditions
Sponsors
Protein Design Labs, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females, 18 years of age or older. 2) Diagnosis of UC verified by colonoscopy or barium enema performed within 36 months prior to consent. 3) Severe active disease, as defined by a Modified Truelove & Witts’ Severity Index (MTWSI; also known as Lichtiger Score) greater than or equal to 11 at consent, with a confirmatory MTWSI greater than or equal to 10 on or after the fifth consecutive day of IV steroids and within 1 day prior to randomization. 4) Mayo score greater than or equal to 10 and a Mayo mucosal subscore greater than or equal to 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids. 5) Adequate contraception from the day of consent through 3 months after the last dose of study drug. 6) Negative serum pregnancy test at screening. 7) Negative Clostridium difficile test within 10 days prior to the first dose of study drug. 8) Signed and dated informed consent and HIPAA if applicable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) UC requiring immediate surgical, endoscopic, or radiologic interventions. 2) History of prior colorectal surgery or ileostomy. 3) White blood cell count less than 2.5 x 10 to the power 3/mcL; platelet count less than 150 x 10 to the power 3/mcL; or hemoglobin level less than 8 g/dL. 4) Active medically significant infections, including prior opportunistic infections within the past 12 months. 5) Live vaccination within 6 weeks prior to randomization. 6) History of deep vein thrombosis or pulmonary embolus. 7) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality. 8) History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated. 9) Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV). 10) Pregnancy or nursing. 11) Infliximab treatment within 4 weeks of first dose or 2 weeks of subsequent dose. 12) Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization. 13) Treatment with any other investigational drugs or therapies within 60 days prior to randomization. 14) Initiation or increase of dosing of 6-mercaptopurine, azathioprine, or methotrexate within 60 days immediately prior to randomization. 15) Failure to discontinue any UC drug (including but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, prior to randomization. 16) Nontherapeutic levels of chronic anti-seizure medications in subjects with a prior history of seizures. 17) Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC. ;Secondary Objective: Secondary: To compare the safety, immunogenicity, health-related quality of life, and pharmacoeconomic outcomes of visilizumab to placebo in IV steroid-refractory UC subjects.;Primary end point(s): The comparison of the proportion of subjects who respond to treatment on Day 45 (± 4 days) in the visilizumab and placebo groups. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary
Outcome results
None listed