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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00279422
• Date of registration: 17/01/2006
• Prospective Registration: Yes
• Primary sponsor: Facet Biotech
• Public title: A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
• Scientific title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
• Date of first enrolment: February 2006
• Target sample size: 127
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00279422
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Netherlands, Norway, Slovakia, Ukraine, United States

Key inclusion & exclusion 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)-a drug within 4 weeks of randomization, or treatment with a subsequent dose of
an anti-TNF-a 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: visilizumab

Secondary ID(s)

291-415

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PDL BioPharma, Inc.