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

March 8, 2012 updated by: Facet Biotech

A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

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
      • Fremantle, Australia, 6160
      • Herston, Australia, QLD 4029
      • Liverpool, Australia, 2170
    • Victoria
      • Box Hill, Victoria, Australia, 3128
  • Austria
      • Wien, Austria, A-1090
  • Belgium
      • Ghent, Belgium, B-9000
      • Leuven, Belgium, 3000
  • Canada
      • Calgary, Canada, T2N 4N1
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
  • Croatia
      • Osijek, Croatia, 31000
      • Zagreb, Croatia, HR-10000
  • Czech Republic
      • Brno, Czech Republic
      • Praha, Czech Republic, 120 00
  • France
      • Clichy, France, 92110
      • Lille, France, 59037
      • Paris, France, 75010
  • Germany
      • Berlin, Germany, D-13353
      • Freiburg, Germany, D-79106
      • Kiel, Germany, D-24105
  • Hungary
      • Csabai kapu, Hungary, H-3501
      • Szekszárd, Hungary
      • Vac, Hungary, H-2601
      • Vasvári Pál, Hungary, H-9024
  • Israel
      • Tel Hashomer, Israel, 52621
  • Italy
      • Bologna, Italy, 40138
  • Netherlands
      • Amsterdam, Netherlands, 1105
  • Norway
      • Oslo, Norway
      • Tromso, Norway
  • Ukraine
      • Odessa, Ukraine, 65025
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Worcester, Massachusetts, United States, 01655
    • New York
      • New York, New York, United States, 10029
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Pittsburgh, Pennsylvania, United States, 15261
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2285
    • Utah
      • Murray, Utah, United States, 84107

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.
  • 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.

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: CROSSOVER
  • Masking: TRIPLE

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.

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

August 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

  • 291-417

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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