SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD)

Juventas Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Peripheral Arterial Disease

Treatments: Biological: Placebo; Biological: JVS-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT02544204

JTCS-007

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• Age ≥18

• Currently receiving standard of care wound treatment (>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.

• Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and <25 cm2. Index wounds on the heel must be <10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.

• Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:

  • TBI ≤ 0.51or;
  • Toe pressure ≤50 mmHg with flat or dampened wave forms or;
  • Skin Perfusion pressure ≤40 mmHg at mid foot level or;
  • TcPO2 ≤40 mmHg

• Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug

Major Exclusion Criteria:

• Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
• Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
• Staged or planned intervention in the index leg within 30 days after the index procedure
• Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
• Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
• Wounds that have decreased in size by >50% between the Screening visit and Day 0.
• If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
• Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
• Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

8 mg JVS-100

Active Comparator group

Description:

Biological/Vaccine: JVS-100 Injection Intramuscular Injection

Treatment:

Biological: JVS-100

8 mg placebo

Placebo Comparator group

Description:

Biological/Vaccine: Placebo Injection Intramuscular Injection

Treatment:

Biological: Placebo

16 mg JVS-100

Active Comparator group

Description:

Biological/Vaccine: JVS-100 Injection Intramuscular Injection

Treatment:

Biological: JVS-100

16 mg placebo

Placebo Comparator group

Description:

Biological/Vaccine: Placebo Injection Intramuscular Injection

Treatment:

Biological: Placebo