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

Last updated: March 8, 2012
Sponsor: Facet Biotech
Overall Status: Terminated

Phase

2/3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Colic

Treatment

N/A

Clinical Study ID

NCT00279422
291-415
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior toconsent.

  • 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 ≥ 10on or after the fifth consecutive day of intravenous (IV)steroids and within 1 dayprior 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 ofstudy drug.

  • Negative serum pregnancy test.

  • Negative Clostridium difficile test.

  • Signed and dated informed consent and Health Insurance Portability and AccountabilityAct (HIPAA) if applicable.

Exclusion

Exclusion Criteria:

  • UC requiring immediate intervention or toxic megacolon requiring imminentintervention.

  • 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 medicallysignificant 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 thepast 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).

  • Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis Bvirus (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 ofan anti-TNF-α drug within 2 weeks of randomization.

  • Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior torandomization.

  • Treatment with any other investigational drugs or therapies within 60 days prior torandomization, 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 priorhistory of seizures.

  • Any condition that, in the investigator's opinion, makes the subject unsuitable forstudy participation.

Study Design

Total Participants: 127
Study Start date:
February 01, 2006
Estimated Completion Date:
August 31, 2007

Study Description

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

Connect with a study center

  • Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Herston, Queensland 4029
    Australia

    Site Not Available

  • South Brisbane, Queensland
    Australia

    Site Not Available

  • Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Bedford Park, 5042
    Australia

    Site Not Available

  • Fitzroy,
    Australia

    Site Not Available

  • Fremantle, 6160
    Australia

    Site Not Available

  • Parkville,
    Australia

    Site Not Available

  • Wien,
    Austria

    Site Not Available

  • Gent, B-9000
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Roeselare,
    Belgium

    Site Not Available

  • Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • London, Ontario N685W9
    Canada

    Site Not Available

  • Brno, 625 00
    Czech Republic

    Site Not Available

  • Praha,
    Czech Republic

    Site Not Available

  • Amiens, Cedex 80054
    France

    Site Not Available

  • Clichy, 92110
    France

    Site Not Available

  • Lille, 59037
    France

    Site Not Available

  • Marseille,
    France

    Site Not Available

  • NICE Cedex,
    France

    Site Not Available

  • Nantes,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Berlin, 13353
    Germany

    Site Not Available

  • Frankfurt, D-60431
    Germany

    Site Not Available

  • Freiburg,
    Germany

    Site Not Available

  • Hannover, 30625
    Germany

    Site Not Available

  • Kiel, 24105
    Germany

    Site Not Available

  • Munchen,
    Germany

    Site Not Available

  • Rostock, 18055
    Germany

    Site Not Available

  • Stuttgart, 70376
    Germany

    Site Not Available

  • empty

    Argenti Döme, 2601
    Hungary

    Site Not Available

  • Argenti Döme, 2601
    Hungary

    Site Not Available

  • Budapest, H-1088
    Hungary

    Site Not Available

  • Csabai Kapu, 3501
    Hungary

    Site Not Available

  • Debrecen, H-4012
    Hungary

    Site Not Available

  • empty

    Győr, Vasvári Pál, 9024
    Hungary

    Site Not Available

  • Győr, Vasvári Pál, 9024
    Hungary

    Site Not Available

  • empty

    Szekszárd, H-7100
    Hungary

    Site Not Available

  • Szekszárd, H-7100
    Hungary

    Site Not Available

  • empty

    Veszprém, H-8220
    Hungary

    Site Not Available

  • Veszprém, H-8220
    Hungary

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Tel Aviv, 64329
    Israel

    Site Not Available

  • Tel Hashomer, 52621
    Israel

    Site Not Available

  • Amsterdam, 1105
    Netherlands

    Site Not Available

  • Rotterdam,
    Netherlands

    Site Not Available

  • Oslo, N-0027
    Norway

    Site Not Available

  • Prinsens,
    Norway

    Site Not Available

  • empty

    Tromsø, 9038
    Norway

    Site Not Available

  • Tromsø, 9038
    Norway

    Site Not Available

  • Mickieviczova, 81369
    Slovakia

    Site Not Available

  • Kharkiv, 61001
    Ukraine

    Site Not Available

  • Kyiv, 01021
    Ukraine

    Site Not Available

  • Odessa, 65025
    Ukraine

    Site Not Available

  • Los Angeles, California 90048
    United States

    Site Not Available

  • San Francisco, California 94115
    United States

    Site Not Available

  • Gainesville, Florida 32608
    United States

    Site Not Available

  • Tampa, Florida 33606
    United States

    Site Not Available

  • Atlanta, Georgia 30342
    United States

    Site Not Available

  • Macon, Georgia 31201
    United States

    Site Not Available

  • Chicago, Illinois 60637
    United States

    Site Not Available

  • Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Lexington, Kentucky 40536
    United States

    Site Not Available

  • Louisville, Kentucky 40202
    United States

    Site Not Available

  • Boston, Massachusetts 02115
    United States

    Site Not Available

  • Rochester, Minnesota 55905
    United States

    Site Not Available

  • New York, New York 10021
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Charleston, South Carolina 29425
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Galveston, Texas 77555-0764
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.