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

NCT04029116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2023-06-18

Study results available
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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).

Conditions

  • Recurrent Vulvovaginal Candidiasis

Interventions

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

DRUG

Placebo oral tablet

BID (one day) every 4 weeks for a total of 6 dosing days

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Principal Investigators

  • Nkechi Azie, MD · Scynexis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2021-09-01
Completion
2021-11-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029116 on ClinicalTrials.gov