Clinical trial NCT00279435: Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: Intravenous, Steroid-Refractory, Ulcerative Colitis
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
Collaborators: name: PDL BioPharma, Inc.
First posted: 2006-01-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

Detailed description: The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

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

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Murray
country: United States
state: Utah
city: Box Hill
country: Australia
state: Victoria
city: Fremantle
country: Australia
city: Herston
country: Australia
city: Liverpool
country: Australia
city: Wien
country: Austria
city: Ghent
country: Belgium
city: Leuven
country: Belgium
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Calgary
country: Canada
city: Osijek
country: Croatia
city: Zagreb
country: Croatia
city: Brno
country: Czech Republic
city: Praha
country: Czech Republic
city: Clichy
country: France
city: Lille
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Kiel
country: Germany
city: Csabai kapu
country: Hungary
city: Szekszárd
country: Hungary
city: Vac
country: Hungary
city: Vasvári Pál
country: Hungary
city: Tel Hashomer
country: Israel
city: Bologna
country: Italy
city: Amsterdam
country: Netherlands
city: Oslo
country: Norway
city: Tromso
country: Norway
city: Odessa
country: Ukraine
Study officials:
References: