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AMG 162

Phase 3

Low Bone Mineral Density | Small molecule | Musculoskeletal |Amgen Inc.|Last Updated: Aug 1, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325468An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral DensityPHASE3 COMPLETED 200 — — May 1, 2006Aug 2, 2012Aug 1, 2017 - —
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Study Endpoints
Primary Endpoints
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Secondary Endpoints
Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 162EXPERIMENTALAMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
Interventions
NameTypeDescription
AMG 162DRUGAMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
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Eligibility Criteria
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Subject must be ambulatory * Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit * signed informed consent must be obtained before any study-specific procedures Exclusion Criteria: * Experience...

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