This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (NCT04029116), a randomized phase 3 study. The primary outcome is Clinical Success.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04029116 |
| Phase | Phase 3 |
| Condition | Recurrent Vulvovaginal Candidiasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 440 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Scynexis, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Female subjects 12 years and older with recurrent vulvovaginal candidiasis (VVC). The primary outcome population is identified as the Intent-to-Treat Set; the registry record does not give further details about its membership.
Intervention
Oral fluconazole 150 mg every 72 hours for 3 doses, followed by oral ibrexafungerp 300 mg BID for one day every 4 weeks, for a total of 6 dosing days.
Comparator
The same oral fluconazole regimen, followed by oral placebo BID for one day every 4 weeks, for a total of 6 dosing days.
Primary question
At Week 24, what percentage of participants had documented clinical success in the Intent-to-Treat Set? A numerical answer or an estimate comparing the groups is not reported in the registry record.
The clinical question is about the treatment sequence after the fluconazole dosing period: whether the group assigned ibrexafungerp had a different proportion with documented clinical success at Week 24 from the group assigned placebo. Because both arms are described as receiving fluconazole first, the planned contrast concerns the subsequent ibrexafungerp-versus-placebo assignment within that regimen, not ibrexafungerp versus no treatment.
The registry also lists no mycologically proven recurrence and safety and tolerability as secondary outcomes. Those outcomes add different perspectives: one concerns evidence of recurrence, while the other concerns adverse effects and tolerability. Their definitions, assessment schedules, and results are not reported in the registry record. The primary endpoint description likewise does not define the clinical criteria used to classify success. Without those details or a posted group comparison, the clinical question can be stated, but its answer cannot be determined from the record.
3. Trial Design
The registry describes a Phase 3, multicenter, randomized, placebo-controlled, parallel-group trial that was completed. Enrollment is listed as 440. The trial began on 2019-10-21, and primary completion is listed as 2021-09-01. The population was female subjects 12 years and older with recurrent VVC.
Participants were assigned to an ibrexafungerp group or a placebo group. Each arm description includes oral fluconazole 150 mg every 72 hours for 3 doses, followed by either oral ibrexafungerp 300 mg BID or oral placebo BID for one day every 4 weeks, for a total of 6 dosing days. This shared initial regimen is important when describing the comparison: the assigned study treatment differed after the fluconazole dosing period.
The record identifies masking as triple. Its official title also describes the study as double-blind. The registry does not explain the terminology difference or identify which roles were masked. Details about the randomization sequence, allocation concealment, treatment adherence, and permitted additional care are not reported in the registry record.
The primary outcome is clinical success at Week 24, measured as the percentage of subjects with documented clinical success. The specified population is the Intent-to-Treat Set. Enrollment does not establish how many participants contributed to that endpoint, and the record does not provide an endpoint denominator or arm-specific clinical-success counts. It lists 3 outcome measures and 0 analyses. The other named outcomes are no mycologically proven recurrence and safety and tolerability, but the record does not give their assessment details or results.
Random allocation can support a fair comparison when the allocation process is implemented as intended and outcome data are analysed appropriately. Masking can reduce the influence of expectations on care or outcome assessment. These are general design principles, not evidence that bias was absent in this trial. The registry record does not report enough implementation detail to assess those processes fully.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 440 subjects were enrolled into the acute phase of the study with 156 of them discontinuing. 260 then entered into the recurrence phase
Overall Study
| Stage | Ibrexafungerp | Placebo |
|---|---|---|
| STARTED | 130 | 130 |
| Discontinued | 12 | 16 |
| COMPLETED | 118 | 114 |
| NOT COMPLETED | 12 | 16 |
Reasons for not completing this period:
| Reason | Ibrexafungerp | Placebo |
|---|---|---|
| Adverse Event | 0 | 2 |
| Lost to Follow-up | 3 | 5 |
| Physician Decision | 2 | 0 |
| Pregnancy | 1 | 2 |
| Withdrawal by Subject | 4 | 6 |
| Other | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat Set
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Intent-to-Treat Set
| Characteristic | Unit | Ibrexafungerp | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 130 | 130 | 260 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 129 | 130 | 259 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Age, Continuous | years | 34.1 (SD 10.23) | 33.7 (SD 9.29) | 33.9 (SD 9.76) |
| Sex: Female, Male: Female | Participants | 130 | 130 | 260 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 12 | 10 | 22 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 118 | 120 | 238 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 12 | 21 |
| Race (NIH/OMB): White | Participants | 120 | 114 | 234 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 3 |
| Region of Enrollment: United States | Participants | 42 | 43 | 85 |
| Region of Enrollment: Bulgaria | Participants | 37 | 35 | 72 |
| Region of Enrollment: Poland | Participants | 17 | 14 | 31 |
| Region of Enrollment: Russia | Participants | 34 | 38 | 72 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Success, measured over Week 24.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is clinical success at Week 24, described as the percentage of subjects with documented clinical success. It is a binary participant outcome: each participant is classified according to whether the stated success condition was met. The endpoint is assigned to the Intent-to-Treat Set.
A binary endpoint can be useful when the clinical question is whether participants reach a defined state by a specified assessment time. A percentage communicates how common that state was in the analysed population, while a comparison between randomized groups can describe the difference in outcome frequency associated with assignment. In general, this kind of endpoint is most interpretable when the success criteria, assessment procedures, and handling of participants without an assessment are clearly specified.
The registry record does not define the clinical criteria for success, explain how documentation was evaluated, or state how missing Week 24 assessments were handled. It also does not report the number meeting the endpoint in either group, the corresponding percentages, or an estimate of the between-group effect. Therefore the endpoint’s intended meaning is identifiable, but neither the observed success rates nor the precision of a treatment comparison can be assessed from the registry record. The listed secondary outcome concerning mycologically proven recurrence is distinct from this primary clinical-success measure, and the record does not provide enough information to infer how the two outcomes relate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary question and the intended assessment time, but does not report the primary outcome result. There are no posted arm-specific clinical-success counts or percentages, no estimate of the difference between groups, and no confidence interval or p-value for that endpoint. As a result, the registry record does not establish whether the observed primary outcome favored either group or how precisely any difference was estimated.
The safety information is more limited than a complete outcome analysis. For the ibrexafungerp group, the record lists 1 serious adverse event among 130 participants at risk and 66 participants with other adverse events among 130 at risk. For placebo, it lists 0 serious adverse events among 130 participants at risk and 41 participants with other adverse events among 130 at risk. Deaths are listed as 0 in each group. COVID-19 and Influenza are listed as the top serious terms, each with 0.8%. The record does not give further group-specific detail for those terms, the event observation period, or information needed to judge how the events were assessed and attributed.
These figures are counts in the registry’s safety reporting, not a substitute for the primary efficacy outcome. They also do not by themselves establish that a treatment caused an event or that the event counts differ beyond what could arise from chance. General statistical interpretation of event counts depends on denominators, the definition of an event, the period of observation, and the completeness of follow-up. Those details are not all reported in the registry record.
The trial has 440 participants listed for enrollment, while the safety entries identify 130 participants at risk in each group. These values refer to different registry fields, and the record does not explain how the safety populations relate to total enrollment. It would be inappropriate to assume from these figures alone that every enrolled participant was included in the safety counts or to infer why the recorded denominators have this size.
Overall, the available record supports a description of the trial question, intervention sequence, and selected safety counts. It does not support a quantitative conclusion about the primary clinical-success comparison. Such a conclusion would require posted outcome data and an analysis that accounts for uncertainty and the analysis population.
9. Statistical Methods Explained
Clinical trial results are most informative when the outcome definition, analysis population, group counts, effect estimate, and uncertainty are reported together. The registry identifies a binary primary outcome—documented clinical success at Week 24—and names the Intent-to-Treat Set as the population. It does not report the group-level outcome counts or a comparison estimate. This means that a reader can understand the intended endpoint but cannot assess its observed frequency or compare the groups statistically from this record.
Binary outcomes. In general, a binary outcome records whether each participant did or did not meet a defined condition. The number of participants meeting the condition is interpreted alongside the number assessed or analysed. A percentage expresses the frequency within that denominator. An effect estimate can then describe a contrast between groups, using a measure such as a difference in proportions or a relative measure. These summaries answer different questions: an absolute contrast describes a change in frequency, whereas a relative contrast describes frequency in relation to another group. No such primary-outcome estimate is reported in the registry record, so none can be interpreted for this trial.
Uncertainty and confidence intervals. In general, a confidence interval describes a range of values compatible with the observed data under the assumptions of the statistical method. It shows how precisely an effect estimate has been measured; a wide interval indicates less precision than a narrow one. A confidence interval is not a guarantee that the true effect lies within the reported range, and it does not replace consideration of study design or missing data. No confidence interval for clinical success is reported in the registry record. The precision of that outcome comparison therefore cannot be assessed.
A p-value, when reported, measures how unusual data at least as inconsistent with a specified null hypothesis would be under the statistical model and its assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. A p-value is best read with the effect estimate and confidence interval, rather than on its own. The registry record does not report a primary-outcome p-value or a statistical test for the comparison.
Randomization and analysis populations. Random assignment aims to make the treatment groups comparable at the point of assignment, on average. An Intent-to-Treat analysis generally evaluates participants in their assigned groups, although the exact operational definition can vary and needs to be specified. Naming the Intent-to-Treat Set does not reveal how the set was constructed, how participants with no outcome assessment were handled, or whether all randomized participants were included. Those details are not reported in the registry record. In general, excluding participants after randomization can compromise the protection randomization provides, particularly when exclusions are related to assignment or outcome.
Missing outcomes. Missing endpoint data can affect an estimate if the chance of missingness is related to treatment assignment or the likely outcome. General approaches include prespecified rules for classifying participants without an assessment, statistical imputation, and sensitivity analyses that examine alternative assumptions. Each approach depends on assumptions, and the assumptions should be explained. The registry record does not report how missing Week 24 clinical-success data were handled, whether imputation was used, or whether sensitivity analyses were conducted. It is therefore not possible to evaluate the robustness of the primary analysis to missing data.
Multiplicity. A trial may examine more than one outcome, time point, or analysis. When several statistical hypotheses are tested, the chance of a false-positive finding can increase if no adjustment or testing strategy is used. General approaches include prioritizing outcomes in a hierarchy or adjusting the significance threshold across tests. The registry lists 3 outcome measures and 0 analyses, but does not report a multiplicity strategy, a hierarchy of hypotheses, or adjusted results. No claim about multiplicity control can be made from the number of outcome measures alone.
Safety counts and sparse events. Adverse events are commonly summarized as participants with at least one event, event counts, or rates over an observation period. These summaries are not interchangeable. The registry reports participants at risk and participants affected for serious events and other adverse events, but does not state the observation period or provide a fuller event-level account. When events are uncommon, estimates may be imprecise; general statistical methods for sparse data require care, and a small count should not be read as proof of no risk. Here, the serious adverse event counts and deaths are reported, but a formal comparative safety analysis is not.
Planning calculations. A sample-size calculation is a planning exercise, not a measure of the evidence observed in a completed trial. The registry’s stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect specified relative to the observed effect. The record does not report the trial’s own sample-size justification. A planning illustration based on an observed effect should not be described as observed power, and it does not replace the primary outcome estimate or its uncertainty. Any numerical planning result must be interpreted as conditional on its stated assumptions, rather than as an observed trial result.
These general principles explain what would be needed to evaluate the primary comparison. For this record, the main statistical limitation is not a particular choice of test that can be assessed, but the absence of the primary result and details of its analysis. The registry record does not identify the statistical model, test, confidence-interval method, or adjustment strategy used for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures, including clinical success, no mycologically proven recurrence, and safety and tolerability. It records 0 analyses. It does not describe which outcomes were confirmatory, whether the primary outcome had priority over secondary outcomes in a formal testing sequence, or whether any multiplicity adjustment was used. Without that information and without outcome-specific results, the risk of interpreting a chance finding among multiple outcomes cannot be assessed.
The primary analysis population is named as the Intent-to-Treat Set. The registry does not define how that set was formed, provide the number analysed, or explain whether the population includes every randomized participant. It also does not report how missing Week 24 assessments were handled, whether participants were excluded from the analysis, or whether imputation or sensitivity analyses were used. These choices matter because an estimate can depend on how participants without a recorded outcome are treated.
The endpoint is specified at Week 24, but the registry does not report the clinical-success criteria or the statistical method used to compare groups. It also does not give a statistical analysis plan or explain whether interim analyses occurred. These items are not reported in the registry record; their absence should not be replaced by assumptions about the trial’s conduct.
The enrollment total and the safety denominators do not provide an accounting of missing primary outcomes. The relationship between enrollment, randomized participants, the Intent-to-Treat Set, and the safety populations is not reported in the registry record. Consequently, completeness of outcome follow-up and the effect of missing data cannot be judged from the counts available.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ibrexafungerp | 1 | 130 | 0.8% |
| Placebo | 0 | 130 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ibrexafungerp | 0 of 130 |
| Placebo | 0 of 130 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ibrexafungerp | 66 of 130 |
| Placebo | 41 of 130 |
Most frequent serious adverse event terms
| Event term | Organ system | Ibrexafungerp | Placebo |
|---|---|---|---|
| COVID-19 | Infections and infestations | 1 of 130 | 0 of 130 |
| Influenza | Infections and infestations | 1 of 130 | 0 of 130 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ibrexafungerp | Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | 25 of 130 | 11 of 130 |
| Bacterial vaginosis | Infections and infestations | 10 of 130 | 11 of 130 |
| Diarrhoea | Gastrointestinal disorders | 10 of 130 | 5 of 130 |
| Nausea | Gastrointestinal disorders | 7 of 130 | 5 of 130 |
| COVID-19 | Infections and infestations | 7 of 130 | 5 of 130 |
| Abdominal pain upper | Gastrointestinal disorders | 7 of 130 | 4 of 130 |
Serious events with the highest arm-level rate: covid-19 (0.8%), influenza (0.8%).
The registry lists serious adverse events for 130 participants at risk in each group. In the ibrexafungerp group, 1 participant is listed as affected by a serious adverse event; in the placebo group, 0 are listed. Deaths are recorded as 0 in both groups. The record also lists 66 participants with other adverse events in the ibrexafungerp group and 41 in the placebo group, each with 130 participants at risk.
These are descriptive counts. In general, a count of participants affected is different from a count of individual events, because one participant may experience more than one event. The registry does not specify the observation period or provide the full event-level information needed to determine how repeated events, timing, severity, or attribution were handled. It lists COVID-19 and Influenza as the top serious terms, each at 0.8%, but does not report their group-specific distribution in this record.
The counts alone do not establish that an event was caused by assigned treatment, and zero recorded deaths do not establish the absence of all safety risk. Interpreting comparative safety requires attention to denominators, follow-up, event definitions, and uncertainty. A formal comparative safety analysis is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized Phase 3 trial compared an ibrexafungerp regimen with a placebo regimen after fluconazole dosing in female subjects 12 years and older with recurrent VVC. Its primary endpoint was documented clinical success at Week 24 in the Intent-to-Treat Set. This information identifies the question the study was designed to address, but it does not answer that question numerically.
No clinical-success counts, percentages, between-group estimate, confidence interval, or p-value are reported in the registry record. Therefore, the posted information does not show the size or direction of the primary outcome difference, or how precisely such a difference was estimated. It is not possible to conclude from the record whether one group had more clinical successes, whether any observed difference was compatible with chance, or whether it was clinically important.
The safety entries describe selected participant counts: serious adverse events, other adverse events, and deaths. They are useful as a limited description of recorded events, but they are not a complete safety assessment. The observation period, event-level details, group-specific distribution of the listed serious terms, and formal comparative analysis are not reported in the registry record. Counts should not be interpreted as proof that a treatment caused or prevented an event.
In general, a trial result supports an inference about the trial’s studied population and treatment conditions, subject to its design, analysis, and data limitations. It does not automatically establish what would occur in every setting or for every person. For this trial, those broader questions are secondary to a more basic limitation: the primary efficacy result is not reported in the registry record. Any interpretation should distinguish the design and safety counts that are available from the clinical outcome comparison that is not.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized, parallel-group comparison in which both arms include a fluconazole dosing period and then differ in assignment to ibrexafungerp or placebo. That treatment sequence defines the contrast being studied. Describing it accurately avoids treating the question as a comparison of ibrexafungerp with no treatment at all.
The registry specifies a binary clinical-success outcome at Week 24 and identifies the Intent-to-Treat Set. Those features make clear what type of endpoint was intended and which analysis population was named. At the same time, the missing success counts and comparison estimate illustrate why an endpoint description alone is not a result. Without a group contrast and measure of uncertainty, statistical interpretation cannot establish the observed outcome pattern or its precision.
The registry also shows why design labels are not a substitute for methods details. Randomization and masking are important features, but they do not disclose how assignment was implemented, how outcomes were assessed, how missing data were handled, or whether multiple outcomes were addressed in a prespecified way. Those details are not reported in the registry record.
The available safety counts likewise illustrate the limits of descriptive summaries. Counts identify recorded participants affected, but interpretation also depends on follow-up time, definitions, and event-level context. Reporting those counts alongside a transparent analysis would allow more complete assessment, but the registry record does not provide that analysis.
For biostatistical reading, the key distinction is between knowing the trial’s planned question and having data that answer it. This record supports the former and a limited description of safety counts; it does not report the primary efficacy comparison. Recognizing that boundary is essential to avoid turning a completed-trial label or a design description into an unsupported conclusion about outcomes.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting this trial from the registry record is the absence of primary clinical-success results. The record gives the endpoint and its Week 24 timeframe but not the numbers of participants meeting it in either arm, the group percentages, an effect estimate, or its uncertainty. No efficacy conclusion can be drawn from those details alone.
The endpoint description does not specify the clinical criteria for success or how assessments were conducted. Although the Intent-to-Treat Set is named, its membership and size are not reported. The record also does not explain the handling of participants without a Week 24 assessment. These omissions limit evaluation of the endpoint’s reproducibility and of possible bias from missing data.
Statistical methods for the primary comparison are not reported in the registry record. There is no description of the test or model, confidence-interval method, multiplicity strategy, or sensitivity analyses. The record does not explain how the masking classification of triple relates to the official title’s double-blind description. Randomization and masking are stated, but implementation details are unavailable.
Safety interpretation is also constrained. The record gives selected counts and lists COVID-19 and Influenza as serious terms at 0.8% each, but does not describe the event observation period, provide full event-level details, or identify the group distribution for those terms. Enrollment is listed as 440, while the safety entries list 130 at risk in each arm; the relationship between those numbers is not explained. These limitations are specific to what is reported in the registry record and do not establish that corresponding information is absent from other trial materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) — NCT04029116.
- Registry record last updated 2023-06-18; status last verified 2023-05.
- Results first posted 2023-06-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes NCT04029116 as a completed Phase 3, multicenter, randomized, parallel-group, placebo-controlled trial of oral ibrexafungerp in female subjects 12 years and older with recurrent VVC. Enrollment is listed as 440. The primary endpoint is documented clinical success at Week 24 in the Intent-to-Treat Set.
Both arms are described as receiving oral fluconazole 150 mg every 72 hours for 3 doses, followed by either oral ibrexafungerp 300 mg BID or oral placebo BID for one day every 4 weeks, for a total of 6 dosing days. The record lists no mycologically proven recurrence and safety and tolerability as secondary outcomes.
Selected safety counts are reported, but primary clinical-success results and a statistical comparison are not reported in the registry record. Details of missing-data handling, multiplicity, and the primary statistical method are also not reported.