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CTLA4Ig / Abatacept

Phase 2

Psoriasis Vulgaris | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Apr 25, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment144
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00287547Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis VulgarisPHASE2 COMPLETED 144 — — Mar 1, 1997Jan 1, 1998Apr 25, 201110 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
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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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CTLA4Ig / AbataceptDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

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 treatm...

Countries:United States
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