A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00277225
First received: January 12, 2006
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Abatacept
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I,Randomized, Double Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics throughout study period [ Time Frame: Until Day 43 or Day 120 depending on dose level ]

Secondary Outcome Measures:
  • Safety and Immunogenicity throughout study period. [ Time Frame: Until Day 43 or Day 120 depending on dose level and duration of adverse events ]

Estimated Enrollment: 32
Study Start Date: November 1995
Study Completion Date: June 1996
Primary Completion Date: June 1996 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization.
  • Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria.

Exclusion Criteria:

  • Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C.
  • Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277225

Locations
United States, California
California Clinical Trials Medical Group
Beverly Hills, California, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Ralph D. Beasom, M.D. California Institutional Review Board
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00277225     History of Changes
Other Study ID Numbers: IM101-003
Study First Received: January 12, 2006
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014