Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Patients Undergoing Repeat Peripheral Artery Revascularization

Treatments: Drug: CV-18C3; Procedure: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270945

2010-PT017

Details and patient eligibility

About

The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

Full description

Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans.

Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram.
• Subjects will be randomized after angiographic evidence of qualifying lesion

Exclusion criteria

• Acute critical limb ischemia
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

CV-18C3 and standard of care

Experimental group

Description:

CV-18C3 and standard of care

Treatment:

Procedure: Standard of Care

Drug: CV-18C3

standard of care

Active Comparator group

Description:

Percutaneous revascularization

Treatment:

Procedure: Standard of Care