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REGN475

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 27, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment421
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02447276Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or HipPHASE2 COMPLETED 421May 1, 2015Nov 1, 2016Mar 27, 201772 United States
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Study Endpoints
Primary Endpoints
The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.
Baseline to week 16
Secondary Endpoints
Change from baseline to week 16 in the WOMAC physical function subscale score
Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score
Baseline to week 16
Incidence of treatment-emergent adverse events (TEAEs)
Baseline to week 36 (end of study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALGroup A will receive REGN475 dosing regimen 1
Group BEXPERIMENTALGroup B will receive REGN475 dosing regimen 2
Group CEXPERIMENTALGroup C will receive REGN475 dosing regimen 3
Group DEXPERIMENTALGroup D will receive REGN475 dosing regimen 4
Group EEXPERIMENTALGroup E will receive matching placebo
Interventions
NameTypeDescription
REGN475DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites72

Key Inclusion Criteria: 1. Body mass index ≤39 2. Clinical diagnosis of OA of the knee or hip 3. History of inadequate pain relief or intolerance to analgesics used for OA 4. Moderate to severe pain in the index joint 5. History of regular use of analgesic medications for OA pain 6. Willing to disc...

Countries:United States
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