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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT00279422

Run by

Facet Biotech

People needed

127

Starts

2006-02-01

Expected to finish

2007-08-01

Last updated by the study team

2012-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Galveston, Texas, United States
• Study site — Camperdown, New South Wales, Australia
• Study site — Liverpool, New South Wales, Australia
• Study site — Herston, Queensland, Australia
• Study site — South Brisbane, Queensland, Australia
• Study site — Box Hill, Victoria, Australia
• Study site — Bedford Park, Australia
• Study site — Fitzroy, Australia
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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