The trial is taking place at:
A

Arizona Research Center | Phoenix, AZ

Veeva-enabled site

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

H

Helixmith

Status and phase

Enrolling
Phase 3

Conditions

Diabetic Peripheral Neuropathy

Treatments

Biological: Engensis
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04873232
VMDN-003-2b

Details and patient eligibility

About

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.

Full 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 (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).

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

250 participants in 2 patient groups, including a placebo group

Engensis
Experimental group
Description:
Patients who have received Engensis in protocol VMDN-003-2
Treatment:
Biological: Engensis
Placebo
Placebo Comparator group
Description:
Patients who have received Placebo in protocol VMDN-003-2
Treatment:
Other: Placebo

Trial contacts and locations

16

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Central trial contact

Young Joo Park; Thu Doan

Data sourced from clinicaltrials.gov

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