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

This study has been completed.

First Received: February 6, 2006 Last Updated: September 26, 2007 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00287547

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 II

MedlinePlus related topics: Psoriasis

Drug Information available for: Abatacept Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

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

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

Study ID Numbers:	IM101-005
Study First Received:	February 6, 2006
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00287547 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Immunologic Factors
Skin Diseases
Psoriasis

Antirheumatic Agents
Immunosuppressive Agents
Skin Diseases, Papulosquamous
Cytotoxic T-lymphocyte antigen 4

Additional relevant MeSH terms:

Abatacept
Immunologic Factors
Skin Diseases
Psoriasis
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009