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

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.

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Repeat Peripheral Artery Revascularization
• Intervention / Treatment: Drug: CV-18C3; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Sutter Heart & Vascular Institute
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
    • Ocala, Florida, United States, 34471
      • Mediquest Research Group
  • Georgia
    • Thomasville, Georgia, United States, 31799
      • John D. Archbold Memorial Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Univeristy of Cincinnati University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CV-18C3 and standard of care	Drug: CV-18C3; 3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration; Procedure: Standard of Care
Active Comparator: standard of care; Percutaneous revascularization	Procedure: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of CV-18C3	adverse events, vitals signs, physical examination results and clinical laboratory values	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to restenosis and restenosis rates compared between CV-18C3 and controls	Efficacy determination will be derived from observed rates of target vessel occlusion, time to occlusion, incidence of target vessel revascularization procedures and incidence of major adverse cardiovascular events (MACE). ABI measurements and quality of life questionnaire scores will also be collected. Treated subjects will be compared to those randomized to no treatment.	1 year

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Principal Investigator: Hosam El-Sayed, M.D., Ph.D., Methodist Cardiovascular Surgery Associates

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2011
• Primary Completion (Actual): September 30, 2013
• Study Completion (Actual): April 30, 2014

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimated): January 5, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2010-PT017