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

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ClinicalTrials.gov Identifier: NCT04267640
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
AnGes USA, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease Chronic Limb Threatening Ischemia Ischemic Ulcer of Foot Biological: AMG0001 Biological: Placebo Phase 2

Detailed 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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: AMG0001 4mg
AMG0001 4mg + standard wound care
Biological: AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Other Names:
  • HGF plasmid
  • Collategene
  • beperminogene perplasmid

Experimental: AMG0001 8mg
AMG0001 8mg + standard wound care
Biological: AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Other Names:
  • HGF plasmid
  • Collategene
  • beperminogene perplasmid

Placebo Comparator: Placebo
Placebo + standard wound care
Biological: Placebo
Matching placebo




Primary Outcome Measures :
  1. Complete ulcer healing at 6 months [ Time Frame: Month 6 ]
    Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.

  2. Time to complete ulcer healing [ Time Frame: Month 12 ]
    Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.


Secondary Outcome Measures :
  1. The percentage reduction of ulcer size from baseline [ Time Frame: Months 4, 6, 8, 10, 12 ]
  2. Hemodynamic measurements of toe pressure (TP) [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Measure of baseline and change from baseline for hemodynamic parameters

  3. Hemodynamic measurements of ankle systolic pressure (ASP) [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Measure of baseline and change from baseline for hemodynamic parameters

  4. Hemodynamic measurements of ankle brachial index (ABI) [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Measure of baseline and change from baseline for hemodynamic parameters

  5. Hemodynamic measurements of toe brachial index (TBI) [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Measure of baseline and change from baseline for hemodynamic parameters

  6. Hemodynamic measurements of TcPO2 [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Measure of baseline and change from baseline for hemodynamic parameters

  7. Visual Analogue Scale (VAS) [ Time Frame: Months 4, 6, 8, 10, 12 ]
    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."

  8. Occurrence of New Ulcer of the Index leg [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Number of subjects and proportions with new ulcer

  9. Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Number of subjects and proportions with major/minor amputation or revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267640


Contacts
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Contact: Melton Affrime, PharmD +1 908-444-3889 maffrime@anges.co.jp
Contact: Jonathan Wright, Dr.PH, MBA +1 240-780-9036 jwright@anges-usa.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
AnGes USA, Inc.
Investigators
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Principal Investigator: David G Armstrong, MD, DPM, PhD Keck School of Medicine, USC
Principal Investigator: Michael S Conte, MD Division of Vascular and Endovascular Surgery, UCSF
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Responsible Party: AnGes USA, Inc.
ClinicalTrials.gov Identifier: NCT04267640    
Other Study ID Numbers: AG-CLTI-0211
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Ulcer
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases