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OpenTrials
Completed

NCT Number: NCT00287547

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

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

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

CTLA4Ig / Abatacept

Drug

Primary outcomes

  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 outcomes

  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.

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
1997
Primary completion
1998
Study completion
1998
First posted
Feb 7, 2006
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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