Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00287547
• Collaborator: (none)
• Enrollment: 144
• Locations: 10
• Duration (Months): 10.1
• Patients Per Site: 14.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: CTLA4Ig / Abatacept	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
• Study Start Date: Mar 1, 1997
• Actual Primary Completion Date: Jan 1, 1998
• Actual Study Completion Date: Jan 1, 1998

Outcome Measures

Primary Outcome Measures

1. Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study. []

Secondary Outcome Measures

1. Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.

• vulgaris total body surfae area involvement of at least 10%

• Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.

Exclusion Criteria:

• Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.

• Functional class (V (ACR) RA or amyloidosis)

• Active vasculitis (except for subcutaneous rheumatoid nodules).

• Subjects with a history of asthma, angioedema or anaphylaxis.

• Subjects with evidence of active or latent bacterial or viral invedtions.

• Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).

• body weight > 100 kg (or 220 lbs.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	San Diego	California	United States
2	Local Institution	Chicago	Illinois	United States
3	Local Institution	Boston	Massachusetts	United States
4	Local Institution	Ann Arbor	Michigan	United States
5	Local Institution	New Brunswick	New Jersey	United States
6	Local Institution	Portland	Oregon	United States
7	Local Institution	Philadelphia	Pennsylvania	United States
8	Local Institution	Dallas	Texas	United States
9	Local Institution	Salt LAke City	Utah	United States
10	Local Institution	Burlington	Vermont	United States

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00287547
• Other Study ID Numbers: IM101-005
• First Posted: Feb 7, 2006
• Last Update Posted: Apr 25, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Psoriasis; Abatacept

Study Results

No Results Posted as of Apr 25, 2011