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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Primary Purpose

Intravenous Steroid-Refractory Ulcerative Colitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Visilizumab (HuM291; Nuvion®)
Sponsored by
Facet Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravenous Steroid-Refractory Ulcerative Colitis focused on measuring Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females, 18 years of age or older.
  • Diagnosis of UC verified by endoscopy within 60 months prior to consent.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2007
    Last Updated
    June 23, 2009
    Sponsor
    Facet Biotech
    Collaborators
    PDL BioPharma, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00502294
    Brief Title
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
    Official Title
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Facet Biotech
    Collaborators
    PDL BioPharma, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intravenous Steroid-Refractory Ulcerative Colitis
    Keywords
    Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Visilizumab (HuM291; Nuvion®)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females, 18 years of age or older. Diagnosis of UC verified by endoscopy within 60 months prior to consent.

    12. IPD Sharing Statement

    Links:
    URL
    http://www.pdl.com
    Description
    Related Info

    Learn more about this trial

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

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