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

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)

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).

Study Overview

• Status: Completed
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Fluconazole Tablet; Drug: IBREXAFUNGERP; Drug: Placebo oral tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials LLC
  • California
    • San Diego, California, United States, 92111
      • Women's Healthcare Research Corp
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research - Hunt - PPDS
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data Inc
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime - ClinEdge - PPDS
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management
    • New Orleans, Louisiana, United States, 70125
      • Women Under Study, LLC
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Unified Women's Clinical Research
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Center For Women's Health and Wellness LLC
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Obstetrics Gynecology Clinical Research LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research and Wellness Center
    • Greensboro, North Carolina, United States, 27408
      • Unified Womens Clinical Research
    • Raleigh, North Carolina, United States, 27607
      • Unified Women's Clinical Research Raleigh
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Group For Women
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Obstetrics and Gynecology Associates of Erie, PC
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research Inc
    • Memphis, Tennessee, United States, 38120
      • Medical Research Center of Memphis, LLC
  • Texas
    • Houston, Texas, United States, 77054
      • TMC Life Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibrexafungerp; Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days	Drug: Fluconazole Tablet; 150 mg every 72 hours for 3 doses; Drug: IBREXAFUNGERP; 300 mg BID (one day) every 4 weeks for a total of 6 dosing days; Other Names: SCY-078
Placebo Comparator: Placebo; Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days	Drug: Fluconazole Tablet; 150 mg every 72 hours for 3 doses; Drug: Placebo oral tablet; BID (one day) every 4 weeks for a total of 6 dosing days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Efficacy as measured by the percentage of subjects with documented Clinical Success.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects With no Mycologically Proven Recurrence	Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence	Week 24
Safety and Tolerability	Safety as measured by the number of subjects who discontinue due to treatment related adverse events.	Week 24

Collaborators and Investigators

• Sponsor: Scynexis, Inc.
• Investigators: Study Director: Nkechi Azie, MD, Scynexis, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: SCY-078; RVVC; Ibrexafungerp; Recurrent yeast infection; Recurrent yeast vaginitis; Chronic yeast vaginitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Candidiasis; Recurrence; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Ibrexafungerp
• Other Study ID Numbers: SCY-078-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No