A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss

Stop-PAD [NCT02544204]

Description:  To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 2 days and 3 months following the procedure.
Biological: JVS-100; Biological: Placebo

Primary Investigator: Reginelli

Drug/Device Information
To assess efficacy of JVS-100 (1 mg/mL) administered by direct intramuscular injection
Adjunct to open bypass grafting or endovascular treatment of popliteal/infrapopliteal lesions in subjects with advanced peripheral artery disease (PAD) and tissue loss (ulceration and/or gangrene)
JVS-100, a non-viral plasmid encoding stromal derived factor -1 (SDF-1)
Randomized in a 2:2:1:1 manner to one of 4 treatment arms 8 x 1 mL JVS-100 injections, 16 x 1 mL JVS-100 injections, 8 x 1 mL placebo, or 16 x 1 mL placebo
Enrolled within 2 days following a successful open bypass grafting or endovascular treatment of popliteal/infrapopliteal lesions
An extension to 3 or 4 days post revascularization is allowed if dosing date falls on a weekend or holiday
Two administrations of JVS-100 will be delivered to patients, one at Day 0 and one at 3 months
Juventas Therapeutics, Inc.
Major Inclusion and Exclusion
Age ≥ 18
Currently receiving standard of care wound treatment for chronic wounds or gangrene
Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg
An ulcer size of at least 0.5 cm2, a smaller sized ulcer penetrating into the subcutaneous tissue, and/or gangrene (dry)
Successful open bypass grafting or endovascular intervention of an a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss
No significant improvement in TBI post intervention
No Previous major amputation of the index leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment
No acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
No clinical evidence of invasive infection in the index leg (e.g., cellulitis, osteomyelitis without planned amputation, wet gangrene) at enrollment