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
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: 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

ClinicalTrials.gov processed this record on September 16, 2014