NCT02544204

SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Juventas Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 12 days and 3 months following the procedure.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
BIOLOGICAL	JVS-100	Biological/Vaccine: JVS-100 Intramuscular Injection
BIOLOGICAL	Placebo	Biological/Vaccine: Placebo Intramuscular Injection

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-09-01
• Completion: 2017-11-01
• First posted: 2015-09-09
• Last updated: 2016-11-02

Locations

24 sites across 1 country: United States