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balicatib

Phase 2

Knee Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Mar 28, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment223
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00371670Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the KneePHASE2 COMPLETED 223Dec 1, 2004 -Mar 28, 20172 United States, Germany
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Study Endpoints
Primary Endpoints
Change from baseline in knee cartilage volume in the target compartment after 6 months
Secondary Endpoints
Change from baseline in:
- Cartilage volume in the different regions of the knee after 6 and 12 months,
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
balicatib (AAE581)DRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * At least one knee with osteoarthritis with Kellgren-Lawrence grade 3 * Significant osteoarthritis pain in the knee * Presence of at least one of the risk factors: obesity (BMI \> 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement Excl...

Countries:United StatesGermany
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