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
1 other identifier
interventional
259
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2015
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedStudy Start
First participant enrolled
February 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2017
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 4, 2020
October 1, 2020
1.7 years
October 8, 2014
October 9, 2020
October 9, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 1. \>0% to ≤10% nail involvement 2. \>10% to \<25% nail involvement 3. ≥25% to ≤50% nail involvement 4. \>50% to ≤75% nail involvement 5. \>75% nail involvement
48 weeks
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
9 months
Study Arms (5)
Low dose 12-week
EXPERIMENTAL2 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
Low dose 24-week
EXPERIMENTAL2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
High dose 12-week
EXPERIMENTAL4 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
High dose 24-week
EXPERIMENTAL4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
Placebo
PLACEBO COMPARATOR4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viametlead
Study Sites (33)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
Radiant Research
Tucson, Arizona, 85712, United States
Dermatology Specialists, Inc
Oceanside, California, 92056, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Center For Clinical Research
San Francisco, California, 94115, United States
Radiant Research
Santa Rosa, California, 95405, United States
International Dermatology Research
Miami, Florida, 33144, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Gateway Health Center
Newburgh, Indiana, 47630, United States
Mid Atlantic Research Center for Health
Baltimore, Maryland, 21214, United States
Associated Skin Care Specialist Minnesota Clinical Study Center
Minneapolis, Minnesota, 55432, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Forest Hills Dermatology Group
Forest Hills, New York, 11395, United States
Skin Search of Rochester
Rochester, New York, 14623, United States
Radiant Research
Akron, Ohio, 44311, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Radiant Research
Columbus, Ohio, 43212, United States
Oregon Dermatology & Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Paddington Testing Company
Philadelphia, Pennsylvania, 19103, United States
Martin Foot and Ankle
York, Pennsylvania, 17402, United States
Radiant Research
Greer, South Carolina, 29621, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch
Austin, Texas, 78759, United States
J&S Clinical Studies
College Station, Texas, 77845, United States
Ashton Podiatry Associates, PA
Dallas, Texas, 75243, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
The Education And Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 32421854DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr Vice President, Clinical Development
- Organization
- Mycovia Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 17, 2014
Study Start
February 17, 2015
Primary Completion
October 18, 2016
Study Completion
July 7, 2017
Last Updated
November 4, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-10