A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy (REGAiN-1B)

A 6-Month Extension Study Following Protocol VMDN-003-2 - An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Biological: Engensis; Other: Placebo

Detailed Description

The purpose of this 6-month extension study (VMDN-003-2b) is 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. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months.

Participants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.

This extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy, Bedside sensory testing, physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials - Little Rock
  • California
    • Los Angeles, California, United States, 90048
      • California Medical Clinic for Headache
    • Sacramento, California, United States, 95821
      • Clinical Trials Research - Sacramento
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Gateway Clinical Trials, LLC
    • Springfield, Illinois, United States, 62704
      • Foot & Ankle Center of Illinois
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • New York
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Houston, Texas, United States, 77030
      • Nerve And Muscle Center Of Texas
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials LLC
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Norfolk, Virginia, United States, 23510
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Engensis; Patients who have received Engensis in protocol VMDN-003-2	Biological: Engensis; Injections with Engensis in study VMDN-003-2
Placebo Comparator: Placebo; Patients who have received Placebo in protocol VMDN-003-2	Other: Placebo; Injections with Placebo in study VMDN-003-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change in the means of the Worst Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to Day 0 Visit (Study VMDN-003-2), to Day 270, and 7 days prior to the Day 365 Visit for Engensis compared to Placebo. 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 worst daily pain scores recorded for Question 3 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy in the 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 worst pain score in participants, would indicate that the worst pain is declining.	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	Number of participants with adverse events and serious adverse events for Engensis compared to Placebo, including the number of participants with clinically significant laboratory values for Engensis 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	Proportion of Responders (≥ 50% reduction in 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 270 Visit and the 7 days prior to the Day 365 Visit for Engensis 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 270 Visit, and 7 days prior to the Day 365 Visit

Collaborators and Investigators

• Sponsor: Helixmith Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Complications; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: VMDN-003-2b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No