Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

Peripheral Artery Disease Clinical Trial

Official title:

A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267640
• Other study ID #: AG-CLTI-0211
• Status: Recruiting
• Phase: Phase 2
• Start date: January 30, 2020
• Est. completion date: January 2023

Study information

• Verified date: December 2021
• Source: AnGes USA, Inc.
• Contact: Melton Affrime, PharmD
• Phone: +1 908-444-3889
• Email: maffrime[@]anges.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

Description:

This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups:

• 4.0 mg AMG0001 intramuscular (IM) (n = 20)

• 8.0 mg AMG0001 IM (n = 20)

• Placebo IM (n = 20)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1, 2)

• A single measurable ulcer of = 1 cm2 and = 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization

• Subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product

• Subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. Subjects who have a diagnosis of diabetes must have a HbA1c of =12% at Screening

Exclusion Criteria:

• Subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening

• Subjects with severe limb ischemia

• Subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening

• Subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is >10 cm2 in area

• Subjects with hemodynamically significant aorto-iliac occlusive disease

• Subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. If subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure

• Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed

Related Conditions & MeSH terms

• Chronic Limb Threatening Ischemia
• Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
• Ischemia
• Ischemic Ulcer of Foot
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Ulcer

Intervention

Biological:
• AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Gateway Clinical Trials, LLC	Belleville	Illinois
United States	Brigham and Women's Hospital / Harvard Medical School	Boston	Massachusetts
United States	ILD Research Center	Carlsbad	California
United States	Vascular Solutions of North Carolina	Cary	North Carolina
United States	The Lindner Center for Research and Education at the Christ Hospital	Cincinnati	Ohio
United States	BRCR Global	Deerfield Beach	Florida
United States	Rancho Research Institute	Downey	California
United States	Limb Preservation Platform, Inc.	Fresno	California
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	Felix Sigal, D.P.M. A Professional Corporation	Los Angeles	California
United States	Rosalind Franklin University Health Clinics	North Chicago	Illinois
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Foot and Ankle Associates of Southwest Virginia	Salem	Virginia
United States	Center for Clinical Research Inc.	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Goleta Valley Cottage Hospital	Santa Barbara	California
United States	Doctors Research Network	South Miami	Florida
United States	Barry University Clinical Research	Tamarac	Florida
United States	Guardian Research/Florida Cardiology	Winter Park	Florida
United States	Lower Extremity Institute for Research and Therapy (LEIRT)	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AnGes USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete ulcer healing at 6 months	Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.	Month 6
Primary	Time to complete ulcer healing	Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.	Month 12
Secondary	The percentage reduction of ulcer size from baseline		Months 4, 6, 8, 10, 12
Secondary	Hemodynamic measurements of toe pressure (TP)	Measure of baseline and change from baseline for hemodynamic parameters	Months 4, 6, 8, 10, 12
Secondary	Hemodynamic measurements of ankle systolic pressure (ASP)	Measure of baseline and change from baseline for hemodynamic parameters	Months 4, 6, 8, 10, 12
Secondary	Hemodynamic measurements of ankle brachial index (ABI)	Measure of baseline and change from baseline for hemodynamic parameters	Months 4, 6, 8, 10, 12
Secondary	Hemodynamic measurements of toe brachial index (TBI)	Measure of baseline and change from baseline for hemodynamic parameters	Months 4, 6, 8, 10, 12
Secondary	Hemodynamic measurements of TcPO2	Measure of baseline and change from baseline for hemodynamic parameters	Months 4, 6, 8, 10, 12
Secondary	Visual Analogue Scale (VAS)	Measure of baseline and change from baseline for VAS. VAS is a 10-cm line (with score ranges 0 to 10), oriented horizontally; the left end of the line (0 mark) indicates "no pain"; the right end indicates "pain as bad as it can be."	Months 4, 6, 8, 10, 12
Secondary	Occurrence of New Ulcer of the Index leg	Number of subjects and proportions with new ulcer	Months 4, 6, 8, 10, 12
Secondary	Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg	Number of subjects and proportions with major/minor amputation or revascularization	Months 4, 6, 8, 10, 12