CompletedNCT05399641Updated Jul 10, 2024Results posted

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

A Phase 3 interventional study of Ibrexafungerp in Vulvovaginal Candidiasis, sponsored by Scynexis, Inc.. Completed at 25 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Scynexis, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 150
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.

Read the detailed description

This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.

Approximately 150 eligible subjects will be enrolled. Subjects will be randomized to receive oral ibrexafungerp 300 mg administered twice a day (BID) for either one, three, or seven consecutive days, stratified by group based on Candida species and presence or absence of underlying medical conditions.

The primary endpoint for this study is the percentage of subjects with a clinical cure at the Test of Cure Visit. Test of Cure is defined as a score of zero on the Vulvovaginal Signs and Symptoms Scale and not requiring additional antifungal treatment.

Conditions studied

Vulvovaginal Candidiasis

Browse trials for

Candidiasis, Vulvovaginal 109

Keywords

vulvovaginal candidiasis
candida
VVC
rVVC
Ibrexafungerp
yeast vaginitis

In context

Candidiasis, Vulvovaginal

109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.

This study's enrollment of 150 is above the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.

Browse Candidiasis, Vulvovaginal studies →

Lead sponsor

Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is a post menarchal female ≥18 years of age at the time of signing the ICF.
Subject has a diagnosis of symptomatic VVC that meets the following criteria at the
Screening visit:
1. Minimum composite vulvovaginal signs and symptoms score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater on the VSS scale at baseline.
2. Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
3. Normal vaginal pH (≤ 4.5).
4. Has no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).
Subject should also have:
1. A VVC with persistent symptoms despite fluconazole therapy (last dose of fluconazole must have been administered at least 7 days prior, but no longer than 28 days prior to screening. OR
2. A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR
3. A VVC episode caused by a non-albicans candida species known to have either intrinsic resistance to fluconazole e.g. C.krusei or suspected resistance to fluconazole, e.g. C.glabrata, C. auris but likely without MIC data in hand. OR
4. A VVC episode caused by Candida species with documented resistance to fluconazole based on MIC determination. OR
5. A known history of azole allergy or intolerance.
Subject is able to take oral tablets.
Subject is not pregnant or lactating and plans not to become pregnant. Women of \< 1 year must agree to and comply with using one barrier method (male condom, female condom, and diaphragm) plus one other highly effective method of , or sexual abstinence, from the time of consent through 10 days after the completion of study therapy. Subjects must refrain from using any topical vaginal contraceptives as these may have an impact on the signs and symptoms of VVC. Note: Women of childbearing potential must have a negative urine pregnancy test prior to enrollment (performed by the site's local laboratory).
Subject is able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.
Subject is able 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 US Health Information Portability and Accountability Act Authorization form).
Subject is able to understand and follow all study-related procedures including study drug administration.

Exclusion criteria

Exclusion Criteria:

Subject has any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy, such as concurrent causes of vulvovaginitis and/or cervicitis including bacterial vaginosis, Trichomonas, Herpes virus, Neisseria gonorrhoeae, Chlamydia, symptomatic human papillomavirus infection, or other mixed infections.
Subject received systemic and/or topical vaginal antifungal treatment, including prescription or over-the-counter products, within 7 days prior to the Screening visit.
Note: The screening visit may be rescheduled if required.
Subject is receiving or anticipates requiring treatment with the prohibited medications within the specified timeframes per Appendix I.
Subject has active menstruation at the Screening visit. Note: The Screening visit may be rescheduled if required.
Subject has a history of or an active cervical/vaginal cancer.
Subject has a known to any of the components of the formulation.
Subject has participated in any other study within at least 30 days (or 5.5 half- lives of the investigational product) before signing the ICF.
Subject has received prior treatment with ibrexafungerp.
Subject has any other condition or laboratory abnormality (such as severe hepatic impairment) that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
Subject is unlikely to comply with protocol requirements.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 150 participants (actual)

Study arms

Experimental
Group A
Subjects without underlying medical conditions and have isolates other than C glabrata, C krusei, C auris. Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Drug: Ibrexafungerp
Experimental
Group B (3 Day dosing)
Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Drug: Ibrexafungerp
Experimental
Group B (7 Day dosing)
Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Drug: Ibrexafungerp

Interventions

DrugIbrexafungerp
Each day dosing will consist of two 150mg tablets taken BID.

What researchers measure

Primary outcomes

Clinical Cure
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline - Test-Of-Cure (TOC)

Secondary outcomes

Clinical Improvement
Percentage of participants with a Total Composite Score of ≤1 on the VSS Scale and a Total Composite Score of ≤2 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Clinical Success
Percentage of participants with at least 50% reduction from baseline in the total composite VSS score and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Mycological Response
Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Clinical Cure and Mycological Response
The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Clinical Cure at Follow-up
The number (percentage) of participants with a total composite score of 0 on the VSS scale and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
The mean change in total composite vulvovaginal signs and symptom (VSS) score from Baseline to TOC and Follow-up Visits. The VSS score ranges from 0 (no signs and symptoms) to a maximum of 18, with higher scores being worse.
Time frame: From Baseline to 14 days post-Baseline (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Clinical Improvement - 2
Percentage of subjects with a Total Composite Score of 2 on the VSS Scale or a composite score of 1 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment, 30 days post-Baseline, 30 days post-End of Treatment and 60 days post- End of Treatment

Results

Posted Jul 10, 2024

Participant flow

Participant flow — Overall Study
Milestone	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
Started	27	62	61
Completed	18	40	42
Not completed	9	22	19
Withdrew: Adverse event	0	1	1
Withdrew: Lost to follow-up	1	2	2
Withdrew: Physician decision	1	3	3
Withdrew: Withdrawal by subject	4	11	7
Withdrew: Reason not defined	3	5	6

Outcome measures

PrimaryClinical Cure

Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

Time frame:: 14 days post-Baseline - Test-Of-Cure (TOC)
Reported as:: Count of participants · Participants

Clinical Cure
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
Clinical Cure	7	10	23

SecondaryClinical Improvement

Percentage of participants with a Total Composite Score of ≤1 on the VSS Scale and a Total Composite Score of ≤2 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

Time frame:: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Reported as:: Count of participants · Participants

Clinical Improvement
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
VSS Score ≤1, (TOC)	10	20	29
VSS Score ≤2, (TOC)	11	23	33
VSS Score ≤1, (14 days post-EOT)	3	8	22
VSS Score ≤1, (30 days post-Baseline)	10	18	24
VSS Score ≤1, (30 days post-EOT	3	8	20
VSS Score ≤1, (60 days post-EOT)	8	18	21
VSS Score ≤2, (14 days post-EOT)	3	10	26
VSS Score ≤2, (30 days post-Baseline)	10	20	26
VSS Score ≤2, (30 days post-EOT)	3	8	20
VSS Score ≤2, (60 days post-EOT)	8	18	24

SecondaryClinical Success

Percentage of participants with at least 50% reduction from baseline in the total composite VSS score and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

Time frame:: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Reported as:: Count of participants · Participants

Clinical Success
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
TOC	11	31	39
14 days post-EOT	3	12	28
30 days post-Baseline	10	23	27
30 days post-EOT	3	9	22
60 days post-EOT	8	18	25

SecondaryMycological Response

Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done

Time frame:: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Reported as:: Count of participants · Participants

Mycological Response
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
TOC	9	23	31
14 days post-EOT	3	8	21
30 days post-Baseline	7	18	25
30 days post-EOT	3	9	20
60 days post-EOT	9	19	24

SecondaryClinical Cure and Mycological Response

The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits

Time frame:: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Reported as:: Count of participants · Participants

Clinical Cure and Mycological Response
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
TOC	5	7	16
14 days post-EOT	3	5	13
30 days post-Baseline	7	15	20
30 days post-EOT	3	8	17
60 days post-EOT	8	17	20

SecondaryClinical Cure at Follow-up

The number (percentage) of participants with a total composite score of 0 on the VSS scale and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

Time frame:: 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Reported as:: Count of participants · Participants

Clinical Cure at Follow-up
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
14 days post-EOT	3	6	17
30 days post-Baseline	7	16	21
30 days post-EOT	3	8	17
60 days post-EOT	8	17	20

SecondaryChange in Total Composite Vulvovaginal Signs and Symptom Score From Baseline

The mean change in total composite vulvovaginal signs and symptom (VSS) score from Baseline to TOC and Follow-up Visits. The VSS score ranges from 0 (no signs and symptoms) to a maximum of 18, with higher scores being worse.

Time frame:: From Baseline to 14 days post-Baseline (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Reported as:: Mean · Score on a scale

Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
Score on a scale	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
TOC	-7.2 (-15 to 0)	-6.3 (-13 to 4)	-8.1 (-16 to 2)
14 days post-EOT	-10.0 (-11 to -8)	-6.7 (-14 to 2)	-7.8 (-16 to 4)
30 days post-Baseline	-7.0 (-17 to 9)	-7.1 (-13 to 3)	-8.3 (-17 to 5)
30 days post-EOT	-10.7 (-11 to -10)	-7.6 (-13 to 0)	-8.0 (-16 to 9)
60 days post-EOT	-8.3 (-17 to -3)	-8.2 (-16 to 2)	-8.5 (-16 to 2)

SecondaryClinical Improvement - 2

Percentage of subjects with a Total Composite Score of 2 on the VSS Scale or a composite score of 1 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

Time frame:: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment, 30 days post-Baseline, 30 days post-End of Treatment and 60 days post- End of Treatment
Reported as:: Count of participants · Participants

Clinical Improvement - 2
Participants	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
VSS Score of 1 at TOC	3	10	6
VSS Score of 1 at 14 days post-EOT	0	2	5
VSS Score of 1 at 30 days post-Baseline	3	2	3
VSS Score of 1 at 30 days post-EOT	0	0	3
VSS Score of 1 at 60 days post-EOT	0	1	1
VSS Score of 2 at TOC	1	3	4
VSS Score of 2 at 14 days post-EOT	0	2	4
VSS Score of 2 at 30 days post-Baseline	0	2	2
VSS Score of 2 at 30 days post-EOT	0	0	0
VSS Score of 2 at 60 days post-EOT	0	0	3

Adverse events

Collected over From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	0/27 (0%)	0/27 (0%)	12/27 (44.4%)
Group B (3 Day Dosing)	0/62 (0%)	0/62 (0%)	35/62 (56.5%)
Group B (7 Day Dosing)	0/61 (0%)	0/61 (0%)	39/61 (63.9%)

Most frequent other events

Most frequent other events
Event	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)
DiarrhoeaGastrointestinal disorders	6/27	18/62	20/61
NauseaGastrointestinal disorders	3/27	16/62	7/61
Bacterial vaginosisGastrointestinal disorders	3/27	1/62	5/61
HeadacheGastrointestinal disorders	1/27	5/62	6/61
ConstipationGastrointestinal disorders	0/27	1/62	5/61
Abdominal DiscomfortGastrointestinal disorders	0/27	3/62	4/61

Baseline characteristics

Intent- to Treat Set (ITT) - all ibrexafungerp-treated participants

Age, Continuous
Age, Continuous(years)	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)	Total
Mean	40.2 ± 14.80	39.6 ± 13.50	39.3 ± 11.43	39.6 ± 12.87

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)	Total
Female	27	62	61	150
Male	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)	Total
Hispanic or Latino	6	14	18	38
Not Hispanic or Latino	21	48	43	112
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group A	Group B (3 Day Dosing)	Group B (7 Day Dosing)	Total
American Indian or Alaska Native	0	0	1	1
Asian	1	3	0	4
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	11	15	14	40
White	13	42	45	100
More than one race	0	0	0	0
Unknown or Not Reported	2	2	1	5

Study locations

25 sites

Precision Trials, AZ
Phoenix, Arizona 85032, United States
Women's Healthcare Research
San Diego, California 92111, United States
Wake Research (MCCR)
San Diego, California 92120, United States
New Age Medical Research
Miami, Florida 33186, United States
Wake (Mount Vernon Clinical Research)
Atlanta, Georgia 30328, United States
Clinical Research Prime
Idaho Falls, Idaho 83404, United States
Leavitt Women's Healthcare
Idaho Falls, Idaho 83404, United States
Women Under Study
New Orleans, Louisiana 70125, United States
Massachusetts's General
Boston, Massachusetts 02114, United States
Wayne State University
Detroit, Michigan 48201, United States
Consultants in Women's Healthcare
Saint Louis, Missouri 63131, United States
Wake Research (CRCN)
Las Vegas, Nevada 89123, United States
Capital Health Lawrence OBGYN
Lawrenceville, New Jersey 08648, United States
Center for Colposcopy
Lake Success, New York 11042, United States
Wake Research (Carolina Institute for Clinical Research)
Fayetteville, North Carolina 28303, United States
UWCR - Raleigh
Raleigh, North Carolina 27607, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina 27103, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Oregon Health and Science University
Portland, Oregon 97239, United States
Jefferson University
Philadelphia, Pennsylvania 19107, United States
Medical Research Center
Memphis, Tennessee 38120, United States
Discovery Clinical Trials
Dallas, Texas 75230, United States
TMC Life Research, Inc
Houston, Texas 77054, United States
Discovery Clinical Trials
McAllen, Texas 78503, United States
Seattle Clinical Research Center
Seattle, Washington 98105, United States

References and documents

Study documents

Study protocol ↗ · Jan 17, 2022
Statistical analysis plan ↗ · Sep 11, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05399641
Lead sponsor: Scynexis, Inc.
Responsible party: Sponsor
First posted: Jun 1, 2022
Start date: May 1, 2022
Primary completion: May 16, 2023
Completion: Aug 2, 2023
Results posted: Jul 10, 2024
Last update: Jul 10, 2024

Study contacts

Lori Tierney

study director · Scynexis, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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