NCT02973893

Study of VF001-DP in Patients With Chronic Venous Leg Ulcers

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients With Chronic Venous Leg Ulcers

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Factor Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.

Detailed description

Objective: The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to Placebo with SC over the course of the 12-week Treatment Phase. Design: This study is a multi-center, randomized, double-blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this trial. The study will have three (3) phases: Screening (2 weeks), Treatment Phase (12 weeks) and Follow-Up (12 weeks). Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment group (VF001-DP low or high dose plus SC) or the Control Treatment group (Placebo plus SC) in a ratio of 1:1:1. Treatment: Eligible patients will be assigned to one of the following treatment groups: * Placebo and SC * VF001-DP (14 micrograms per treatment) and SC (low dose \[LD\]) * VF001-DP (140 micrograms per treatment) and SC (high dose \[HD\]). The investigational product (IP), i.e., VF001-DP and placebo, will be supplied in 1 mL syringes each containing 0.5 mL of either VF001-DP or Placebo. The IP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein (vitronectin, amino acids 1-64 of the human sequence and IGF-I amino acids 1-70 of the human sequence), 14 μg or 140 μg protein in 0.5 mL of Phosphate Buffered Saline, pH 7.2. VF001-DP is manufactured utilizing an expression vector system in yeast to Good Manufacturing Practice (GMP) and is not made with and does not include any products of human or animal origin. Number of Patients: It is planned to recruit 168 patients (56 per treatment group) at 26 centres in USA for this study.

Conditions

• Ulcer
• Leg Ulcer
• Varicose Ulcer
• Pathologic Processes
• Skin Ulcer
• Skin Diseases
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo
BIOLOGICAL	VF001-DP LD	VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
BIOLOGICAL	VF001-DP HD	VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-11-01
• Completion: 2019-02-01
• First posted: 2016-11-25
• Last updated: 2018-09-25

Locations

17 sites across 1 country: United States