A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.

• Conditions: Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis; MedDRA version: 6.1Level: PTClassification code 10009900

• Registration Number: EUCTR2005-003482-17-IT
• Lead Sponsor: PDL BioPharma , Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 11 at consent, with a confirmatory MTWSI 10 on or after the fifth consecutive day of IV steroids and within 1 day prior to randomization.4 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. 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 randomization. 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

1 UC requiring immediate intervention.2 History of prior colorectal surgery or ileostomy.3 White blood cell count less than 2.5 x 103/mcL; platelet count less than 150 x 103/mcL; or hemoglobin level less than 8 g/dL.4 Medically significant infections, particularly those of viral etiology. This includes any incidence of 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-treated subjects may not receive study drug until 4 weeks after their first dose or 2 weeks after a subsequent dose of infliximab. 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 antiseizure 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with IVSR-UC, and to evaluate optimum dosing.;Secondary Objective: not applicable;Primary end point(s): The primary endpoint will be the comparison of the proportion of subjects in each treatment group that respond on Day 45 for Phase 1, the dose exploration phase. A subject will be defined as being a responder if there has been a 3-point reduction in the total Mayo score with a rectal bleeding subscore reduced by at least 1 or an actual bleeding subscore of 0 to 1.