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HP-802-247

Phase 3

Venous Leg Ulcers | Monoclonal antibody | Other |Smith & Nephew SNATS, Inc.|Last Updated: Mar 14, 2016

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment447
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01656889Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg UlcersPHASE3 COMPLETED 447Aug 1, 2012Dec 1, 2014Mar 14, 201650 United States, Canada
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Study Endpoints
Primary Endpoints
Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
12 Weeks

For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

Secondary Endpoints
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.
12 Weeks
Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline
Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Target ulcer status observed at two and three months following initial ulcer closure.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HP802-247EXPERIMENTALHP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
VehiclePLACEBO_COMPARATORVehicle Control (fibrinogen solution \& thrombin solution without cells)
Interventions
NameTypeDescription
HP-802-247BIOLOGICALHP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
VehicleBIOLOGICAL(fibrinogen solution \& thrombin solution without cells)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Provide informed consent. * Age ≥ 18 years and of either sex. * Willing to comply with protocol instructions, including allowing all study assessments. * Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 1...

Countries:United StatesCanada
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