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

March 8, 2012 updated by: Facet Biotech

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
      • Fitzroy, Australia
      • Fremantle, Australia, 6160
      • Parkville, Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Liverpool, New South Wales, Australia, 2170
    • Queensland
      • Herston, Queensland, Australia, 4029
      • South Brisbane, Queensland, Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
  • Austria
      • Wien, Austria
  • Belgium
      • Gent, Belgium, B-9000
      • Leuven, Belgium, 3000
      • Roeselare, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • Ontario
      • London, Ontario, Canada, N685W9
  • Czech Republic
      • Brno, Czech Republic, 625 00
      • Praha, Czech Republic
  • France
      • Clichy, France, 92110
      • Lille, France, 59037
      • Marseille, France
      • NICE Cedex, France
      • Nantes, France
      • Paris, France
    • Cedex
      • Amiens, Cedex, France, 80054
  • Germany
      • Berlin, Germany, 13353
      • Frankfurt, Germany, D-60431
      • Freiburg, Germany
      • Hannover, Germany, 30625
      • Kiel, Germany, 24105
      • Munchen, Germany
      • Rostock, Germany, 18055
      • Stuttgart, Germany, 70376
  • Hungary
      • Argenti Döme, Hungary, 2601
      • Budapest, Hungary, H-1083
      • Budapest, Hungary, H-1088
      • Csabai Kapu, Hungary, 3501
      • Debrecen, Hungary, H-4012
      • Győr, Vasvári Pál, Hungary, 9024
      • Szekszárd, Hungary, H-7100
      • Veszprém, Hungary, H-8220
  • Israel
      • Haifa, Israel
      • Tel Aviv, Israel, 64329
      • Tel Hashomer, Israel, 52621
  • Netherlands
      • Amsterdam, Netherlands, 1105
      • Rotterdam, Netherlands
  • Norway
      • Oslo, Norway, N-0027
      • Prinsens, Norway
      • Tromsø, Norway, 9038
  • Slovakia
      • Mickieviczova, Slovakia, 81369
  • Ukraine
      • Kharkiv, Ukraine, 61001
      • Kyiv, Ukraine, 01021
      • Odessa, Ukraine, 65025
  • United States
    • California
      • Los Angeles, California, United States, 90048
      • San Francisco, California, United States, 94115
    • Florida
      • Gainesville, Florida, United States, 32608
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Macon, Georgia, United States, 31201
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Galveston, Texas, United States, 77555-0764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: visilizumab
Experimental: visilizumab
Drug: visilizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Facet Biotech

Collaborators

PDL BioPharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291-415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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