NCT02679456

Brief Summary

This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2016

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

January 19, 2016

Last Update Submit

July 10, 2019

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)

    Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).

    Day 24 +/- 3

Secondary Outcomes (1)

  • Proportion of subjects with recurrence of VVC during the observation period

    4-month observation period

Study Arms (3)

Treatment Group 1 (Fluconazole)

ACTIVE COMPARATOR

Fluconazole

Drug: Fluconazole

Treatment Group 2: (SCY-078)

EXPERIMENTAL

Dose regimen 1

Drug: SCY-078

Treatment Group 3 (SCY-078)

EXPERIMENTAL

Dose regimen 2

Drug: SCY-078

Interventions

SCY-078DRUG
Treatment Group 2: (SCY-078)Treatment Group 3 (SCY-078)
FluconazoleDRUG
Treatment Group 1 (Fluconazole)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must fulfill all of the following criteria to be eligible for study admission:
  • Female subjects from 18 to 65 years of age in good general health
  • Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
  • The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
  • The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
  • The ability to understand and follow all study-related procedures including study drug administration.
  • Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.

You may not qualify if:

  • Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
  • Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
  • a. Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.
  • Subjects with history of renal impairment, hepatic impairment or cervical cancer.
  • Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
  • \. HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Dr. Francisco E. Moscoso Puello

Santo Domingo, Dominican Republic

Location

Instituto Dermatologico y Cirugia de Piel

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

ibrexafungerpFluconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Angulo, MD

    Scynexis, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 10, 2016

Study Start

November 1, 2015

Primary Completion

August 5, 2016

Study Completion

August 5, 2016

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

DO(2)