NCT04055090

Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Long-term, Prospective, Non-interventional, Extension of a Phase III, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety & Efficacy of Engensis (VM202) in Subjects With Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.

Detailed description

In the phase III VMDN-003 study, subjects received 2 treatments of either Engensis (VM202) or placebo administered as intramuscular injections into bilateral calves on Days 0 and 14, and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection. The growth potential for Hepatocyte Growth Factor make long-term follow-up important both for safety and efficacy: in order for Engensis to be a candidate for chronic treatment of Painful Diabetic Peripheral Neuropathy, it must be demonstrated not to induce unexpected adverse events with repeated dosing; and the potential for reversal or stabilization of diabetic neuropathy using only one or two treatments of Engensis may make it especially attractive compared to current treatments which must be taken daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore warranted.

Conditions

• Painful Diabetic Neuropathy
• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
GENETIC	Long-Term Follow-Up of Patients who Received Engensis (VM202)	No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
DRUG	Long-Term Follow-Up of Patients who Received Placebo	No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-07-24
• Completion: 2019-07-24
• First posted: 2019-08-13
• Last updated: 2025-10-09
• Results posted: 2023-03-08

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study