Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

Official Title

A Randomized, Double-Blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Conditions

Ulcerative Colitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcomes: Clinical response

Secondary Outcomes: The comparison of subjects in the visilizumab and placebo groups in the following categories: clinical remission; mucosal healing; symptomatic response and the time to symptomatic response; symptomatic remission; time to disease progression; colectomy rates; time to colectomy; safety; immunogenicity; health-related quality of life; pharmacoeconomic outcomes

The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

Study Start

January 17, 2006

Eligibility & Criteria

Inclusion Criteria:

• Males and females, 18 years of age or older.
• Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
• Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
• Active disease at screening, and symptomatic worsening
• Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization.
• 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 surgical, endoscopic, or radiologic interventions.
• White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin less than 8 g/dL.
• Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
• Live vaccination within 6 weeks prior to randomization.
• History of deep vein thrombophlebitis or pulmonary embolus.
• Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
• History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated.
• Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
• Pregnancy or nursing.
• Treatment with any other UC salvage drugs (including but not limited to infliximab, cyclosporine, tacrolimus [FK506], adalimumab, and thalidomide) or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study.
• Treatment with any other investigational drug or therapy within 60 days prior to randomization.
• Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures.
• Any condition that, in the investigators opinion, makes the subject unsuitable for study participation.

Total Enrolment

Expected Total Enrollment: 80

Contact Details

Liverpool Hospital, Liverpool, 2170, Australia Anne Glass 61-2-9828-3571 Susan Connor, MD, Principal Investigator