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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306878
First Posted: March 27, 2006
Last Update Posted: April 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Resource links provided by NLM:


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
Study Completion Date: May 1997
Primary Completion Date: May 1997 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00306878     History of Changes
Other Study ID Numbers: IM101-001
First Submitted: March 23, 2006
First Posted: March 27, 2006
Last Update Posted: April 13, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents