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HOE140 Icatibant

Phase 2

Joint Disease | Small molecule | Musculoskeletal |Sanofi|Last Updated: Feb 17, 2012

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 Enrollment590
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00303056Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee OsteoarthritisPHASE2 COMPLETED 590 — — Feb 1, 2006Jul 1, 2007Feb 17, 20125 United States, Austria +3
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Study Endpoints
Primary Endpoints
Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).
Secondary Endpoints
Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
HOE140 IcatibantDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male and female subjects with painful osteoarthritis of the knee. Exclusion Criteria: * Subjects presenting with diagnosis of OA \< 3 months and an OA grading \< K\&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, a...

Countries:United StatesAustriaCzechiaGermanyPoland
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