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Alefacept

Phase 3

Psoriasis | Small molecule | Immunology |Biogen Inc.|Last Updated: Sep 18, 2014

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 Trials2
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00692172Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque PsoriasisPHASE3 COMPLETED 175Dec 1, 2001Nov 1, 2004Sep 18, 201443 United States, Belgium +7
NCT00301002Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar PustulosisPHASE2 COMPLETED 15Jun 1, 2005Oct 1, 2006Nov 23, 20061 Canada
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Study Endpoints
Primary Endpoints
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Throughout treatment course
percentage change in PPPASI from baseline
Secondary Endpoints
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Every 2 weeks throughout treamtent course
number of subjects with PPPASI 75
number of subjects with PPPASI 50
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
AlefaceptDRUGintramuscular injection (IM)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR, * Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not ...

Countries:United StatesBelgiumCanadaDenmarkFranceGermanyNetherlandsSpainUnited Kingdom
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