Clinical trial NCT01270945: Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.
Official title: Phase II Open Label,Randomized Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody(CV-18C3)in Reducing Restenosis in Patients Undergoing Percutaneous Femoro-popliteal Revascularization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients Undergoing Repeat Peripheral Artery Revascularization
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of CV-18C3
timeFrame: 1 year
Secondary outcomes:
measure: Time to restenosis and restenosis rates compared between CV-18C3 and controls
timeFrame: 1 year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Heart & Vascular Institute
state: California
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Mediquest Research Group
state: Florida
city: Thomasville
country: United States
facility: John D. Archbold Memorial Hospital
state: Georgia
city: Cincinnati
country: United States
facility: Univeristy of Cincinnati University Hospital
state: Ohio
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Methodist Cardiovascular Surgery Associates
name: Hosam El-Sayed, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Sayed H, Kerensky R, Stecher M, Mohanty P, Davies M. A randomized phase II study of Xilonix, a targeted therapy against interleukin 1alpha, for the prevention of superficial femoral artery restenosis after percutaneous revascularization. J Vasc Surg. 2016 Jan;63(1):133-41.e1. doi: 10.1016/j.jvs.2015.08.069. Epub 2015 Oct 1.