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

AnGes

Status and phase: Unknown; Phase 2

Conditions: Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease; Peripheral Artery Disease; Chronic Limb Threatening Ischemia; Ischemic Ulcer of Foot

Treatments: Biological: Placebo; Biological: AMG0001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04267640

AG-CLTI-0211

Details and patient eligibility

About

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.

Full 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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

AMG0001 4mg

Experimental group

Description:

AMG0001 4mg + standard wound care

Treatment:

Biological: AMG0001

AMG0001 8mg

Experimental group

Description:

AMG0001 8mg + standard wound care

Treatment:

Biological: AMG0001

Placebo

Placebo Comparator group

Description:

Placebo + standard wound care

Treatment:

Biological: Placebo