Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Recurrent Vulvovaginal Candidiasis Clinical Trial

— CANDLE  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029116
• Other study ID #: SCY-078-304
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2019
• Est. completion date: November 29, 2021

Study information

• Verified date: May 2023
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Description:

This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.

Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 29, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

• Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.

• History of 3 or more episodes of VVC in the past 12 months.

• Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).

• Able to take oral tablets and capsules.

Key exclusion Criteria:

• Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.

• Recent use of systemic and/or topical vaginal antifungal products.

• Pregnant.

• History of major system organ disease.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrence
• Recurrent Vulvovaginal Candidiasis

Intervention

Drug:
• Fluconazole Tablet
150 mg every 72 hours for 3 doses
• IBREXAFUNGERP
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
• Placebo oral tablet
BID (one day) every 4 weeks for a total of 6 dosing days

Locations

Country	Name	City	State
United States	Bosque Women's Care	Albuquerque	New Mexico
United States	Chattanooga Medical Research Inc	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	Clinical Trials Management	Covington	Louisiana
United States	Wayne State University	Detroit	Michigan
United States	Carolina Women's Research and Wellness Center	Durham	North Carolina
United States	Obstetrics and Gynecology Associates of Erie, PC	Erie	Pennsylvania
United States	Unified Womens CLinical Research	Greensboro	North Carolina
United States	Unified Women's Clinical Research	Hagerstown	Maryland
United States	TMC Life Research Inc	Houston	Texas
United States	Clinical Research Prime - ClinEdge - PPDS	Idaho Falls	Idaho
United States	Altus Research - Hunt - PPDS	Lake Worth	Florida
United States	Center For Women's Health and Wellness LLC	Lawrenceville	New Jersey
United States	Lawrence Obstetrics Gynecology Clinical Research LLC	Lawrenceville	New Jersey
United States	Medical Research Center of Memphis, LLC	Memphis	Tennessee
United States	New Age Medical Research Corporation	Miami	Florida
United States	Women Under Study, LLC	New Orleans	Louisiana
United States	Healthcare Clinical Data Inc	North Miami	Florida
United States	Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Precision Trials LLC	Phoenix	Arizona
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Unified Women's Clinical Research Raleigh	Raleigh	North Carolina
United States	Women's Healthcare Research Corp	San Diego	California
United States	Group For Women	Winston-Salem	North Carolina
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	Efficacy as measured by the percentage of subjects with documented Clinical Success.	Week 24
Secondary	The Percentage of Subjects With no Mycologically Proven Recurrence	Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence	Week 24
Secondary	Safety and Tolerability	Safety as measured by the number of subjects who discontinue due to treatment related adverse events.	Week 24