Overview

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

Status:
Terminated
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Facet Biotech
Collaborator:
PDL BioPharma, Inc.
Treatments:
Visilizumab
Criteria
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.