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

NCT01410331 | Completed Phase 2 DMC

• 1 other identifier: JTCS-002
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

Brief 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).

Conditions

Critical Limb Ischemia

Keywords

CLI; peripheral vascular disease; PVD; PAD; SDF-1

Outcome Measures

Primary Outcomes (1)

• To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.

  Safety assessments include tracking of AEs and SAEs and laboratory assessments

  12 Months

Secondary Outcomes (1)

• To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.

  6 months

Study Arms (4)

Cohort 1

EXPERIMENTAL

Subjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections.

Biological: JVS-100(4 mg) or placebo/8 injections

Cohort 2

EXPERIMENTAL

Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections.

Biological: JVS-100(8 mg) or placebo/8 injections

Cohort 3

EXPERIMENTAL

Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections.

Biological: JVS-100(8 mg) or placebo/16 injections

Cohort 4

EXPERIMENTAL

Subjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections.

Biological: JVS-100(16 mg) or placebo/16 injections

Interventions

JVS-100(4 mg) or placebo/8 injections BIOLOGICAL

4 mg of JVS-100 or placebo delivered in 8 injections

Cohort 1

JVS-100(8 mg) or placebo/8 injections BIOLOGICAL

8 mg of JVS-100 or placebo delivered in 8 injections

Cohort 2

JVS-100(8 mg) or placebo/16 injections BIOLOGICAL

8 mg of JVS-100 or placebo delivered in 16 injections

Cohort 3

JVS-100(16 mg) or placebo/16 injections BIOLOGICAL

16 mg of JVS-100 or placebo delivered in 16 injections

Cohort 4

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 40 years of age or older
• Rutherford Category 4 or 5
• Ankle systolic pressure of 70mmHg or less, or toe pressure of 50mmHg or less
• Poor option for surgical revascularization by open or endovascular strategies
• Those diabetic subjects who are on optimal diabetes treatment, with HbA1c \<8.5 %
• Subject should be on stable therapy for the treatment of CLI, including statin and antiplatelet therapy
• Subject must be willing to forgo treatment with hyperbaric oxygen, nerve stimulation, ot sympathectomy for treatment of CLI 10 days prior to 45 days following injection of study drug

You may not qualify if:

• Life expectancy of less than 1 year
• Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
• Patent revascularization (within 6 weeks)in the leg to be treated prior to enrollment
• NYHA Class IV heart failure
• Evidence of osteomyelitis or active infection
• Subjects with Buerger's Disease
• Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
• Subjects with established chronic kidney (stage 5) requiring dialysis
• Uncontrolled blood pressure
• Significant hepatic disease
• Diabetic subjects with active proliferative retinopathy
• Immunodeficient states or subjects receiving chronic immunosuppressive therapy
• Any patient with a history of cancer unless 1)the cancer was limited to curable non-melanoma skin malignancies, or 2)the cancer was removed by successful tumor resection, with or without radiation or chemotherapy, 5 years or more prior to enrollment in this study without recurrence
• Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
• Men unwilling to agree to barrier contraception or limit sexual activity

Sponsors & Collaborators

• Juventas Therapeutics, Inc.: lead

Study Sites (7)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Northwestern Memorial Hospital/Northwestern University

Chicago, Illinois, 60611, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Medanta-The Medicity

Haryāna, 122001, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Melina Kibbe, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: August 5, 2011
• Study Start: March 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

US (5); IN (2)