Clinical trial NCT00279422: A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
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: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Galveston
country: United States
state: Texas
city: Camperdown
country: Australia
state: New South Wales
city: Liverpool
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: South Brisbane
country: Australia
state: Queensland
city: Box Hill
country: Australia
state: Victoria
city: Bedford Park
country: Australia
city: Fitzroy
country: Australia
city: Fremantle
country: Australia
city: Parkville
country: Australia
city: Wien
country: Austria
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Brno
country: Czech Republic
city: Praha
country: Czech Republic
city: Amiens
country: France
state: Cedex
city: Clichy
country: France
city: Lille
country: France
city: Marseille
country: France
city: Nantes
country: France
city: NICE Cedex
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Munchen
country: Germany
city: Rostock
country: Germany
city: Stuttgart
country: Germany
city: Argenti Döme
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Csabai Kapu
country: Hungary
city: Debrecen
country: Hungary
city: Győr, Vasvári Pál
country: Hungary
city: Szekszárd
country: Hungary
city: Veszprém
country: Hungary
city: Haifa
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Amsterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Oslo
country: Norway
city: Prinsens
country: Norway
city: Tromsø
country: Norway
city: Mickieviczova
country: Slovakia
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Odessa
country: Ukraine
Study officials:
References:
citation: Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.