A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail

Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.

The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: Placebo; Drug: VT-1161

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic of UAB Hospital
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Radiant Research
  • California
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
    • Santa Rosa, California, United States, 95405
      • Radiant Research
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Gateway Health Center
  • Maryland
    • Baltimore, Maryland, United States, 21214
      • Mid Atlantic Research Center for Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55432
      • Associated Skin Care Specialist Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • Forest Hills, New York, United States, 11395
      • Forest Hills Dermatology Group
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
    • Columbus, Ohio, United States, 43212
      • Radiant Research
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company
    • York, Pennsylvania, United States, 17402
      • Martin Foot and Ankle
  • South Carolina
    • Greer, South Carolina, United States, 29621
      • Radiant Research
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch
    • College Station, Texas, United States, 77845
      • J&S Clinical Studies
    • Dallas, Texas, United States, 75243
      • Ashton Podiatry Associates, PA
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation, Inc.
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.

Positive culture for dermatophytes and positive KOH.

Nail ≤ 3 mm thick at the distal end.

At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

Subjects must be able to swallow tablets.

Women of childbearing potential and males must use acceptable birth control methods throughout the study.

Key Exclusion Criteria:

Presence of subungual hematoma or melanonychia.

Presence of dermatophytoma/nail streaks and severe onychorrhexis.

Significant dystrophy or anatomic abnormalities of the great toenail.

Presence of any other infections of the foot.

Evidence of clinically significant major organ disease.

Poorly controlled diabetes mellitus.

Onychomycosis involving more than 8 toe nails.

Recent use of systemic antifungal therapy.

Recent of any topical antifungal nail therapy.

Recent use of systemic corticosteroid therapy.

Recent use of immunosuppressive medication.

History of prolonged QT intervals.

Known human immunodeficiency virus (HIV) infection.

Known significant renal or hepatic impairment.

Known history of intolerance or hypersensitivity to azole antifungal drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose 12-week; 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks	Drug: VT-1161
Experimental: Low dose 24-week; 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks	Drug: VT-1161
Experimental: High dose 12-week; 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks	Drug: VT-1161
Experimental: High dose 24-week; 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks	Drug: VT-1161
Placebo Comparator: Placebo; 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement; >0% to ≤10% nail involvement; >10% to <25% nail involvement; ≥25% to ≤50% nail involvement; >50% to ≤75% nail involvement; >75% nail involvement	48 weeks
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities		9 months

Collaborators and Investigators

• Sponsor: Viamet

Publications and helpful links

General Publications

• Elewski B, Brand S, Degenhardt T, Curelop S, Pollak R, Schotzinger R, Tavakkol A. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail. Br J Dermatol. 2021 Feb;184(2):270-280. doi: 10.1111/bjd.19224. Epub 2020 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2015
• Primary Completion (Actual): October 18, 2016
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: VMT-VT-1161-CL-005