Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00279435
• Date of registration: 17/01/2006
• Prospective Registration: Yes
• Primary sponsor: Facet Biotech
• Public title: Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
• Scientific title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
• Date of first enrolment: August 2006
• Target sample size: 25
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00279435
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females, 18 years of age or older.

- Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab
study).

- Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative
colitis (IVSR-UC) disease to visilizumab or placebo.

- Symptomatic worsening (ie, an increase of =3 points in MTWSI score) from the
subject's best response on the parent study, an MTWSI score of =9, sustained for at
least 2 assessments performed at least 1 week apart, and a confirmatory MTWSI =8
within 1 day prior to randomization.

- CD4^+ T-cell count = 200 cells/mcL at screening for this protocol, or = 80% of the
subject's screening baseline count prior to enrollment on the parent study.

- Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded
evaluating physician within 2 weeks prior to randomization.

- 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 surgical, endoscopic, or radiologic interventions.

- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x
10^3/mcL; or hemoglobin less than 8 g/dL.

- Active, medically significant infections, particularly those of viral etiology, eg,
known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic
infections within the past 12 months.

- Live vaccination within 6 weeks prior to randomization.

- Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary,
vascular, gastrointestinal, endocrine, or laboratory abnormality, history of
myocardial infarction, coronary artery disease, congestive heart failure, or
arrhythmias within 6 months prior to consent.

- History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma
skin cancer or carcinoma in situ of the cervix that has been adequately treated
within the past five years.

- Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B
virus (HBV) surface antigen, or hepatitis C virus (HCV).

- Pregnancy or nursing.

- Treatment with any other UC salvage drugs (including but not limited to infliximab or
another anti-TNF-a drug, cyclosporine, tacrolimus [FK506], adalimumab, thalidomide,
or another experimental agent), or therapies (surgery, pheresis, affinity columns)
since the first course of treatment with study drug in the parent visilizumab study.

- Treatment with any other investigational drug or therapy within 60 days prior to
randomization.

- Nontherapeutic levels of chronic antiseizure medications in subjects with a 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)

291-417

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PDL BioPharma, Inc.