A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

NCT04873232 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: VMDN-003-2b
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 16

Brief Summary

To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo

  Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine. The mean of at least 5 daily pain scores recorded for Question 5 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy scale in electronic diary during the 7 days prior to the visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the average daily pain score in participants, would indicate that the average daily pain is declining.

  From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population

Secondary Outcomes (3)

• To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo

  From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit for Engensis compared to Placebo

• To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to Placebo

  From Day 0 Visit (Study VMDN-003-2) to the Day 365 Visit

• To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs

  From the 7 days prior to the Day 0 Visit (Study VMDN-003-2), to the 7 days prior to the Day 270 Visit, and 7 days prior to the Day 365 Visit

Study Arms (2)

Engensis

EXPERIMENTAL

Patients who have received Engensis in protocol VMDN-003-2

Biological: Engensis

Placebo

PLACEBO COMPARATOR

Patients who have received Placebo in protocol VMDN-003-2

Other: Placebo

Interventions

Engensis BIOLOGICAL

Injections with Engensis in study VMDN-003-2

Engensis

Placebo OTHER

Injections with Placebo in study VMDN-003-2

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b

You may not qualify if:

• None

Sponsors & Collaborators

• Helixmith Co., Ltd.: lead

Study Sites (16)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Clinical Trials - Little Rock

Little Rock, Arkansas, 72205, United States

Location

California Medical Clinic for Headache

Los Angeles, California, 90048, United States

Location

Clinical Trials Research - Sacramento

Sacramento, California, 95821, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Gateway Clinical Trials, LLC

O'Fallon, Illinois, 62269, United States

Location

Foot & Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

ClinPoint Trials LLC

Waxahachie, Texas, 75165, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Results Point of Contact

• Title: Jinsub Lee, PhD
• Organization: Helixmith, Co., LTD

jinsub.lee@helixmith.com

+82-10-8256-0439

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: May 5, 2021
• Study Start: May 17, 2021
• Primary Completion: September 14, 2023
• Study Completion: July 23, 2024
• Last Updated: October 9, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-08

Locations

US (16)