Diabetic Peripheral NeuropathyPhase 3REGAiN-1BNCT04873232
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
A Phase 3 study testing Engensis in people with Diabetic Peripheral Neuropathy, run by Helixmith Co., Ltd. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Engensis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 May 2021to 23 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b
Who cannot join
- None
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Clinical Research Professionals
Chesterfield, Missouri, 63005
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Nerve and Muscle Center of Texas
Houston, Texas, 77030
Clinical Trials - Little Rock
Little Rock, Arkansas, 72205
California Medical Clinic for Headache
Los Angeles, California, 90048
Manassas Clinical Research Center
Manassas, Virginia, 20110
Futuro Clinical Trials
McAllen, Texas, 78501
Eastern Virginia Medical School
Norfolk, Virginia, 23510
Gateway Clinical Trials, LLC
O'Fallon, Illinois, 62269
Arizona Research Center
Phoenix, Arizona, 85053
Health Concepts
Rapid City, South Dakota, 57702
Dominion Medical Associates
Richmond, Virginia, 23219
Clinical Trials Research - Sacramento
Sacramento, California, 95821
Foot & Ankle Center of Illinois
Springfield, Illinois, 62704
Richmond Behavioral Associates
Staten Island, New York, 10314
ClinPoint Trials LLC
Waxahachie, Texas, 75165
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Engensis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngensisBiological
Injections with Engensis in study VMDN-003-2
PlaceboOther
Injections with Placebo in study VMDN-003-2
| Study group | Role | What they receive |
|---|---|---|
| Engensis | Experimental | Patients who have received Engensis in protocol VMDN-003-2 Receives: Biological: Engensis |
| Placebo | Placebo comparator | Patients who have received Placebo in protocol VMDN-003-2 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start17 May 2021
- Primary completion14 Sep 2023
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helixmith Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873232
- Sponsor's protocol ID
- VMDN-003-2b
- Acronym
- REGAiN-1B
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2021
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04873232
- Acronym / sponsor ID
- REGAiN-1B / VMDN-003-2b
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Helixmith Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engensis | Experimental | Biological: EngensisPatients who have received Engensis in protocol VMDN-003-2 |
| Placebo | Placebo comparator | Other: PlaceboPatients who have received Placebo in protocol VMDN-003-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EngensisInjections with Engensis in study VMDN-003-2 | Biological | Engensis |
| PlaceboInjections with Placebo in study VMDN-003-2 | Other | Placebo |
Primary outcome
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
Time frame: 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
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.
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Engensis in people with Diabetic Peripheral Neuropathy, run by Helixmith Co., Ltd. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.