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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00277225
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Abatacept	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• 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
• Study Start Date: Nov 1, 1995
• Actual Primary Completion Date: Jun 1, 1996
• Actual Study Completion Date: Jun 1, 1996

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics throughout study period [Until Day 43 or Day 120 depending on dose level]

Secondary Outcome Measures

1. Safety and Immunogenicity throughout study period. [Until Day 43 or Day 120 depending on dose level and duration of adverse events]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00277225
• Other Study ID Numbers: IM101-003
• First Posted: Jan 16, 2006
• Last Update Posted: Apr 13, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Psoriasis; Abatacept

Study Results

No Results Posted as of Apr 13, 2011