Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

April 11, 2011 updated by: Bristol-Myers Squibb
The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

144

Phase

  • Phase 2

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

  • United States
    • California
      • San Diego, California, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Michigan
      • Ann Arbor, Michigan, United States
        • Local Institution
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
    • Utah
      • Salt LAke City, Utah, United States
        • Local Institution
    • Vermont
      • Burlington, Vermont, United States
        • Local Institution

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
  • vulgaris total body surfae area involvement of at least 10%
  • Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.

Exclusion Criteria:

  • Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
  • Functional class (V (ACR) RA or amyloidosis)
  • Active vasculitis (except for subcutaneous rheumatoid nodules).
  • Subjects with a history of asthma, angioedema or anaphylaxis.
  • Subjects with evidence of active or latent bacterial or viral invedtions.
  • Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
  • body weight > 100 kg (or 220 lbs.)

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.

Secondary Outcome Measures

Outcome Measure
Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

March 1, 1997

Primary Completion (Actual)

January 1, 1998

Study Completion (Actual)

January 1, 1998

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-005

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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