Clinical trial NCT02267356: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Viamet
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
timeFrame: 48 weeks
measure: Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic of UAB Hospital
state: Alabama
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Francisco
country: United States
facility: Center For Clinical Research
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Newburgh
country: United States
facility: Gateway Health Center
state: Indiana
city: Baltimore
country: United States
facility: Mid Atlantic Research Center for Health
state: Maryland
city: Minneapolis
country: United States
facility: Associated Skin Care Specialist Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch
state: Texas
city: College Station
country: United States
facility: J&S Clinical Studies
state: Texas
city: Dallas
country: United States
facility: Ashton Podiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Lynchburg
country: United States
facility: The Education And Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
References:
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.