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Fasinumab AI

Phase 1

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 3, 2021

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03491904To Assess the Patients' Ability to Self-Administer FasinumabPHASE1 COMPLETED 100Jan 23, 2019Dec 15, 2020Mar 3, 202123 United States
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Study Endpoints
Primary Endpoints
Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting
Baseline to Week 16
Secondary Endpoints
Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
Baseline to Week 16
Number of AI associated product technical complaint (PTCs)
Baseline to Week 16
Number of validated AI associated PTFs
Baseline to Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Auto-injector (AI)EXPERIMENTAL -
Prefilled syringe (PFS)EXPERIMENTAL -
Interventions
NameTypeDescription
Fasinumab AIDRUGSelf-administered with auto injector
Fasinumab PFSDRUGPrefilled syringe administered by study staff
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: 1. A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit 2. Moderate-to-severe pain in the index joint defined as a WOMAC ...

Countries:United States
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