Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00306878

Purpose

The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: Abatacept	Phase I

MedlinePlus related topics: Psoriasis

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer [ Time Frame: at Day 43 ]

Secondary Outcome Measures:

Physician's globas Assessment [ Time Frame: at Day 36 ]
Phage-neutralizing antibody titer [ Time Frame: at Day 16 and Day 29 ]
Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected [ Time Frame: at Day 43 ]

Estimated Enrollment:	45
Study Start Date:	August 1995

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures.
Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration.
Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score [ODSS]of 4-7 inclusive).
Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.

Exclusion Criteria:

Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment.
No clinical response to a prior adequate therapeutic trial of cyclosporin A
Prolonged exposure to the sun within 4 weeks prior to the first dose.
Guttate, erythrodermic, or pustular psoriasis.
Spontaneously improving or rapidly deteriorating psoriasis vulgaris.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306878

Locations

United States, Massachusetts
Local Institution
boston, Massachusetts, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
United States, New York
Local Institution
New York, New York, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More 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

Study ID Numbers:	IM101-001
Study First Received:	March 23, 2006
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00306878
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous
Cytotoxic T-lymphocyte antigen 4

ClinicalTrials.gov processed this record on January 14, 2009