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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00277225
First received: January 12, 2006
Last updated: April 11, 2011
Last verified: April 2011
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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 June 17, 2013