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Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

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

Secondary Outcome Measures

Physician's globas Assessment
Phage-neutralizing antibody titer
Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected

Full Information

First Posted
March 23, 2006
Last Updated
April 11, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00306878
Brief Title
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Official Title
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
May 1997 (Actual)
Study Completion Date
May 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abatacept
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Physician's globas Assessment
Time Frame
at Day 36
Title
Phage-neutralizing antibody titer
Time Frame
at Day 16 and Day 29
Title
Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected
Time Frame
at Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

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