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CureXcell

Phase 3

Lower Extremity Chronic Ulcers in Diabetics | Monoclonal antibody | Other |Icon Plc|Last Updated: Dec 7, 2015

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-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment285
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01421966Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With DiabetesPHASE3 COMPLETED 285 — — Aug 1, 2011Oct 1, 2015Dec 7, 201537 United States, Canada +1
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Study Endpoints
Primary Endpoints
Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up.
up to 20 weeks
Secondary Endpoints
Time to complete closure of the Target Ulcer during the core double blind treatment phase with sustained complete closure for 4 additional weeks of follow-up.
up to 20 weeks
Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
16 weeks
Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
up to 28 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CureXcell®EXPERIMENTAL -
Sham injectionSHAM_COMPARATOR -
Interventions
NameTypeDescription
CureXcell®BIOLOGICALCureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
Sham injectionBIOLOGICALThe sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: 1. Males or females at least 18 years of age with diabetes type 1 or type 2; 2. Patients with HbA1c ≤ 12%; 3. Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), whi...

Countries:United StatesCanadaIsrael
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