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Mechanism of action of alefacept

Phase 2

Psoriasis | Small molecule | Immunology |Biogen Inc.|Last Updated: Aug 7, 2008

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00150982Alefacept Mechanism of Action in PsoriasisPHASE2 COMPLETED 9Sep 1, 2003Feb 1, 2005Aug 7, 20081 United States
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Study Endpoints
Primary Endpoints
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary Endpoints
To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Mechanism of action of alefaceptDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies). Exclusion...

Countries:United States
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