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

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

Detailed Description
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The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular (IM) 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 (ADPS) of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Bedside Sensory Testing (BST), physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs).

Official Title
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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

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Biological: Engensis
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of IM administration of Engensis on pain in Participants with painful DPN in the feet and lower legs as compared to Placebo | Change in the means of the Average Daily Pain Scores (ADPSs) from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome. | From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to 7 days prior to the Day 365 Visit | 

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 DPN 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 (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome. | From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit | 
| To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs | Proportion of Responders (>=50% reduction in the ADPSs from the full BPI-DPN) | 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 | 
| To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs | Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and clinically significant laboratory values | Day 0 to Day 365 |