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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VT-1161
Placebo
Sponsored by
Viamet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Kirklin Clinic of UAB Hospital
  • Radiant Research
  • Dermatology Specialists, Inc
  • Therapeutics Clinical Research
  • Center For Clinical Research
  • Radiant Research
  • International Dermatology Research
  • Radiant Research
  • Northwest Clinical Trials
  • Gateway Health Center
  • Mid Atlantic Research Center for Health
  • Associated Skin Care Specialist Minnesota Clinical Study Center
  • Skin Specialists, PC
  • Academic Dermatology Associates
  • Forest Hills Dermatology Group
  • Skin Search of Rochester
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Oregon Dermatology & Research Center
  • Oregon Medical Research Center
  • Paddington Testing Company
  • Martin Foot and Ankle
  • Radiant Research
  • Coastal Carolina Research Center
  • The Skin Wellness Center
  • Tennessee Clinical Research Center
  • DermResearch
  • J&S Clinical Studies
  • Ashton Podiatry Associates, PA
  • Endeavor Clinical Trials
  • The Education And Research Foundation, Inc.
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose 12-week

Low dose 24-week

High dose 12-week

High dose 24-week

Placebo

Arm Description

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

2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks

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

4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks

4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks

Outcomes

Primary Outcome Measures

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
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities

Secondary Outcome Measures

Full Information

First Posted
October 8, 2014
Last Updated
October 9, 2020
Sponsor
Viamet
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1. Study Identification

Unique Protocol Identification Number
NCT02267356
Brief Title
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2015 (Actual)
Primary Completion Date
October 18, 2016 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viamet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose 12-week
Arm Type
Experimental
Arm Description
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
Arm Title
Low dose 24-week
Arm Type
Experimental
Arm Description
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
Arm Title
High dose 12-week
Arm Type
Experimental
Arm Description
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
Arm Title
High dose 24-week
Arm Type
Experimental
Arm Description
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
Intervention Type
Drug
Intervention Name(s)
VT-1161
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
Description
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
Time Frame
48 weeks
Title
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Kirklin Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Dermatology Specialists, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Center For Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Gateway Health Center
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Mid Atlantic Research Center for Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21214
Country
United States
Facility Name
Associated Skin Care Specialist Minnesota Clinical Study Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11395
Country
United States
Facility Name
Skin Search of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Paddington Testing Company
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Martin Foot and Ankle
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Clinical Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Ashton Podiatry Associates, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Education And Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32421854
Citation
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.
Results Reference
derived

Learn more about this trial

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

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