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gevokizumab

Phase 2

Acne Vulgaris | Small molecule | Dermatology |XOMA Royalty Corporation|Last Updated: Mar 4, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment127
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01498874Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne VulgarisPHASE2 COMPLETED 127Dec 1, 2011Jun 1, 2013Mar 4, 201419 United States
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Study Endpoints
Primary Endpoints
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Baseline and Day 84
Secondary Endpoints
The proportion of subjects with a successful treatment outcome at Day 84
Baseline and Day 84
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
low dose gevokizumabEXPERIMENTAL -
high dose gevokizumabEXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUGSterile solution administered subcutaneously on Day 0, Day 28, and Day 56
gevokizumabDRUGSterile solution administered subcutaneously on Day 0, Day 28, and Day 56
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Eligibility Criteria
Age Range17 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Diagnosis of moderate to severe acne vulgaris * Acne vulgaris unresponsive to oral antibiotics * Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study Exclusion Criteria: * Use of medications or treatme...

Countries:United States
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