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Systemic AMG 108

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |Amgen Inc.|Last Updated: Jun 23, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00110942Treatment for Patients With Osteoarthritis (OA)PHASE2 COMPLETED 160Feb 1, 2005Nov 1, 2005Jun 23, 2008 -
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Study Endpoints
Primary Endpoints
Change in WOMAC pain score
Week 6
Secondary Endpoints
Change in WOMAC pain score
Week 12
Change in WOMAC composite score and function and stiffness index scores
Weeks 6 and 12
Achieving 50% or more improvement from Day 1 in the WOMAC
Weeks 6 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Minor sub-study AMG 108ACTIVE_COMPARATORN = 15
Minor sub-study placeboPLACEBO_COMPARATORN = 15
Main sub-study AMG 108ACTIVE_COMPARATORN = 73
Main sub-study placeboPLACEBO_COMPARATORN = 73
Interventions
NameTypeDescription
Systemic AMG 108DRUG300 mg SC AMG 108 Q4W for 3 doses
PlaceboOTHERSC placebo injection Q4W for 3 doses
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria * Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS) * If currently taking any over the counter nutritional supplements, must be on stable dos...

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