Phase I 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:
NCT00306878
First received: March 23, 2006
Last updated: April 11, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00306878     History of Changes
Other Study ID Numbers: IM101-001
Study First Received: March 23, 2006
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014