A Phase 2 interventional study of Fluconazole and SCY-078 in Candida Vulvovaginitis, 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 2021-08-12.
Sponsored by Scynexis, Inc. · Phase 2, Interventional, and Treatment
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Among 33 studies in Candidiasis, Vulvovaginal with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Candidiasis, Vulvovaginal · United States.
Among the 33 studies in Candidiasis, Vulvovaginal with a site in United States, this one is the 15th largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 in phase 2, and was the 18th registered.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
Browse Candidiasis, Vulvovaginal studies →3 of the 33 studies in Candidiasis, Vulvovaginal with a site in United States are open now. Recruiting first, the newest first:
Sano Chemicals Inc · Sites in United States
Ages 18–65 · Women only
Coologics, Inc · Sites in United States
Ages 22–49 · Women only
Queen's Medical Center · Sites in United States
Ages 18–54 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Candidiasis, Vulvovaginal studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 9 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 186 is above the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Median enrollment 187 across the 28 interventional studies, 300 across the 5 observational. Of the 28 that completed or were terminated, 17 (61%) have results posted.
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24 of 33 have an industry lead sponsor. The 10 most frequent:
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.
Scynexis, Inc. has 8 studies filed under Candidiasis, Vulvovaginal — fewer than ten, so there is no comparison to draw.
2 of the studies in Candidiasis, Vulvovaginal with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07521137Sano Chemicals IncBiweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence | 2026-12-31 |
| NCT05079711Uniformed Services University of the Health SciencesComparative Performance of a Vaginal Yeast Test | 2027-10-30 |
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Among the 33 studies in Candidiasis, Vulvovaginal with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
Key Inclusion Criteria:
Key Exclusion Criteria:
150 mg/day for 1 day
Drug: Fluconazole
750mg QD for 1 day only
Drug: SCY-078
300mg BID for 1 day only
Drug: SCY-078
450mg BID for 1 day only
Drug: SCY-078
150mg BID for 3 days
Drug: SCY-078
300mg BID for 3 days
Drug: SCY-078
Oral Antifungal comparator
Also known as: Diflucan, Azole antifungal
Investigational Antifungal
Also known as: Ibrexafungerp
Clinical Cure (Complete Resolution of Signs and Symptoms)
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Time frame: 8-12 days
Co-occurrence of Clinical and Mycological Cure
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
Time frame: 29 days
Incidence of Treatment Emergent Adverse Events
The number of subjects with treatment related adverse events
Time frame: up to 29 days
| Milestone | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole |
|---|---|---|---|---|---|---|
| Started | 32 | 30 | 28 | 32 | 32 | 32 |
| Subjects discontinued | 4 | 3 | 6 | 4 | 5 | 4 |
| Completed | 28 | 27 | 22 | 28 | 27 | 28 |
| Not completed | 4 | 3 | 6 | 4 | 5 | 4 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 2 | 1 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 | 1 | 0 | 3 | 0 |
| Withdrew: Other | 0 | 1 | 2 | 1 | 0 | 0 |
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
| Participants | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg D1 to D3 | Fluconazole |
|---|---|---|---|---|---|---|
| Clinical cure | 9 | 14 | 13 | 14 | 15 | 14 |
| Clinical failure | 17 | 13 | 8 | 15 | 11 | 10 |
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
| Participants | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg D1 to D3 | Fluconazole |
|---|---|---|---|---|---|---|
| Clinical cure and Mycological Eradication | 4 | 10 | 11 | 8 | 13 | 10 |
| Clinical failure and/or mycological persistence | 22 | 17 | 10 | 21 | 13 | 14 |
The number of subjects with treatment related adverse events
| Participants | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg D1 to D3 | Fluconazole |
|---|---|---|---|---|---|---|
| Treatment related Treatment-emergent adverse event | 20 | 14 | 16 | 12 | 15 | 8 |
| No Treatment related Treatment-emergent adverse event | 12 | 16 | 12 | 19 | 17 | 24 |
Collected over 29 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrexafungerp 750-mg | 0/32 (0%) | 0/32 (0%) | 21/32 (65.6%) |
| Ibrexafungerp 300-mg | 0/30 (0%) | 0/30 (0%) | 13/30 (43.3%) |
| Ibrexafungerp 450-mg | 0/28 (0%) | 0/28 (0%) | 15/28 (53.6%) |
| Ibrexafungerp 150-mg | 0/31 (0%) | 0/31 (0%) | 15/31 (48.4%) |
| Ibrexafungerp 300-mg D1 to D3 | 0/32 (0%) | 0/32 (0%) | 18/32 (56.3%) |
| Fluconazole | 0/32 (0%) | 0/32 (0%) | 10/32 (31.3%) |
| Event | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg D1 to D3 | Fluconazole |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 15/32 | 5/30 | 6/28 | 4/31 | 13/32 | 1/32 |
| HeadacheNervous system disorders | 3/32 | 3/30 | 3/28 | 9/31 | 4/32 | 2/32 |
| NauseaGastrointestinal disorders | 8/32 | 3/30 | 8/28 | 6/31 | 6/32 | 2/32 |
| Abdominal painGastrointestinal disorders | 5/32 | 1/30 | 2/28 | 3/31 | 0/32 | 3/32 |
| VomitingGastrointestinal disorders | 1/32 | 0/30 | 4/28 | 0/31 | 2/32 | 0/32 |
| DizzinessNervous system disorders | 1/32 | 2/30 | 2/28 | 3/31 | 0/32 | 0/32 |
| Abdominal pain upperGastrointestinal disorders | 1/32 | 0/30 | 2/28 | 2/31 | 3/32 | 1/32 |
| PruritusSkin and subcutaneous tissue disorders | 0/32 | 2/30 | 0/28 | 0/31 | 0/32 | 1/32 |
| NasopharyngitisInfections and infestations | 0/32 | 2/30 | 0/28 | 0/31 | 1/32 | 0/32 |
| Blood creatine phosphokinase increasedInvestigations | 2/32 | 1/30 | 0/28 | 2/31 | 0/32 | 1/32 |
| Age, Continuous(years) | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole | Total |
|---|---|---|---|---|---|---|---|
| Mean | 34.6 ± 12.3 | 34.4 ± 11.3 | 34.5 ± 9.8 | 33.3 ± 10.5 | 32.0 ± 8.5 | 33.8 ± 10.1 | 33.7 ± 10.4 |
| Sex: Female, Male(Participants) | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole | Total |
|---|---|---|---|---|---|---|---|
| Female | 32 | 30 | 28 | 32 | 32 | 32 | 186 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 9 | 8 | 11 | 7 | 11 | 56 |
| Not Hispanic or Latino | 22 | 21 | 20 | 21 | 25 | 21 | 130 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 0 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 10 | 12 | 13 | 15 | 13 | 72 |
| White | 22 | 20 | 14 | 18 | 16 | 19 | 109 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Ibrexafungerp 750-mg | Ibrexafungerp 300-mg | Ibrexafungerp 450-mg | Ibrexafungerp 150-mg | Ibrexafungerp 300-mg (3 Days) | Fluconazole | Total |
|---|---|---|---|---|---|---|---|
| United States | 32 | 30 | 28 | 32 | 32 | 32 | 186 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2017 to primary completion in May 2018, 9 months.
Results were first posted in Aug 2021, 3 years 3 months after primary completion. A results delay was requested in Oct 2020.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibrexafungerp
Scynexis, Inc.