A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

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

Detailed Description
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PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Official Title
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A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: visilizumab
* Drug: visilizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: visilizumab<br> <br> |
| Experimental: visilizumab<br> | Drug: visilizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous, Steroid-Refractory, Ulcerative Colitis