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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01410331
• Date of registration: 14/07/2011
• Primary sponsor: Juventas Therapeutics, Inc.
• Public title: Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
• Scientific title: 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
• Date of first enrolment: March 2012
• Target sample size: 48
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01410331
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

India, United States

Contacts

• Name: Joesph Pastore, PhD

• Name: Melina Kibbe, MD
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Presence of any other condition that, in the opinion of the investigator, might
compromise any aspect of the trial

- Acute coronary syndrome within 3 month prior to enrollment

- Previous treatment with angiogenic growth factors or with stem cell therapy within 1
year

- Participation in another clinical trial in the last 30 days

- Clinically significant elevations in PT/PTT/INR

- Non-heel wound size >20 cm2 (excluding toe gangrene) or heel wound size >10cm2 on the
index limb

- History of drug or alcohol abuse in the last year



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critical Limb Ischemia

Intervention(s)

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

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

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

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

Primary Outcome(s)

To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI. [Time Frame: 12 Months]

Secondary Outcome(s)

To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI. [Time Frame: 6 months]

Secondary ID(s)

JTCS-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors