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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00287547
First received: February 6, 2006
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
 Drug: CTLA4Ig / Abatacept
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 144
Study Start Date: March 1997
Study Completion Date: January 1998
Primary Completion Date: January 1998 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287547

Locations
United States, California
Local Institution
San Diego, California, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
United States, New Jersey
Local Institution
New Brunswick, New Jersey, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Texas
Local Institution
Dallas, Texas, United States
United States, Utah
Local Institution
Salt LAke City, Utah, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00287547     History of Changes
Other Study ID Numbers: IM101-005
Study First Received: February 6, 2006
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cytotoxic T-lymphocyte antigen 4
Abatacept
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013