NCT01410331

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection to Cohorts of Adults With Critical Limb Ischemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Juventas Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).

Detailed description

48 subjects diagnosed with Rutherford Class 4-5 Critical Limb Ischemia (CLI) with non-healing ulcers and/or ischemic rest pain will be enrolled in this study designed to investigate the safety and efficacy of JVS-100. JVS-100 will be delivered by direct intramuscular injection into the limbs of study subjects. Subjects will be randomized to receive a single set of direct intramuscular injections of either JVS-100 or vehicle control and will be followed for 12 months post dosing. Safety and efficacy assessments will be collected at 3 days, 4 weeks and 3, 6 and 12 months.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	JVS-100(4 mg) or placebo/8 injections	4 mg of JVS-100 or placebo delivered in 8 injections
BIOLOGICAL	JVS-100(8 mg) or placebo/8 injections	8 mg of JVS-100 or placebo delivered in 8 injections
BIOLOGICAL	JVS-100(8 mg) or placebo/16 injections	8 mg of JVS-100 or placebo delivered in 16 injections
BIOLOGICAL	JVS-100(16 mg) or placebo/16 injections	16 mg of JVS-100 or placebo delivered in 16 injections

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-08-05
• Last updated: 2014-10-23

Locations

7 sites across 2 countries: United States, India