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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287547
• Other study ID #: IM101-005
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: April 11, 2011
• Start date: March 1997
• Est. completion date: January 1998

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 1998
• Est. primary completion date: January 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• CTLA4Ig / Abatacept

Locations

Country	Name	City	State
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Burlington	Vermont
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Dallas	Texas
United States	Local Institution	New Brunswick	New Jersey
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Portland	Oregon
United States	Local Institution	Salt LAke City	Utah
United States	Local Institution	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm