Trial · NCT05399641
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
NCT05399641, Phase 3, Completed, Scynexis, Inc.; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis. Trials, record NCT05399641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05399641
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
- NCT number
- NCT05399641
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Scynexis, Inc.
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- Ibrexafungerp
- First posted
- 2022-06-01
- Last updated
- 2024-07-10
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure | 14 days post-Baseline - Test-Of-Cure (TOC) | 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. |
| Secondary | Clinical Improvement | 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 | 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. |
| Secondary | Clinical Success | 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. | 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. |
| Secondary | Mycological Response | 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. | Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done |
| Secondary | Clinical Cure and Mycological Response | 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 | The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits |
| Secondary | Clinical Cure at Follow-up | 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT | 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. |
| Secondary | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 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 | 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. |
| Secondary | Clinical Improvement - 2 | 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 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure | 14 days post-Baseline - Test-Of-Cure (TOC) | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Improvement | 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 | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success | 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. | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mycological Response | 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. | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure and Mycological Response | 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 | Modified Intent-to-Treat (mITT) - all treated participants who have a positive culture for candida species at Screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at Follow-up | 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 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 | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening | Score on a scale | MEAN |
| SECONDARY | Clinical Improvement - 2 | 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 | Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure | Group A | 7 | Participants | ||
| Clinical Cure | Group B (3 Day Dosing) | 10 | Participants | ||
| Clinical Cure | Group B (7 Day Dosing) | 23 | Participants | ||
| Clinical Improvement | Group A | VSS Score ≤1, (TOC) | 10 | Participants | |
| Clinical Improvement | Group B (3 Day Dosing) | VSS Score ≤1, (TOC) | 20 | Participants | |
| Clinical Improvement | Group B (7 Day Dosing) | VSS Score ≤1, (TOC) | 29 | Participants | |
| Clinical Improvement | Group A | VSS Score ≤2, (TOC) | 11 | Participants | |
| Clinical Improvement | Group B (3 Day Dosing) | VSS Score ≤2, (TOC) | 23 | Participants | |
| Clinical Improvement | Group B (7 Day Dosing) | VSS Score ≤2, (TOC) | 33 | Participants | |
| Clinical Improvement | Group A | VSS Score ≤1, (14 days post-EOT) | 3 | Participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 27 | |
| Overall Study | STARTED | Group B (3 Day Dosing) | 62 | |
| Overall Study | STARTED | Group B (7 Day Dosing) | 61 | |
| Overall Study | COMPLETED | Group A | 18 | |
| Overall Study | COMPLETED | Group B (3 Day Dosing) | 40 | |
| Overall Study | COMPLETED | Group B (7 Day Dosing) | 42 | |
| Overall Study | NOT COMPLETED | Group A | 9 | |
| Overall Study | NOT COMPLETED | Group B (3 Day Dosing) | 22 | |
| Overall Study | NOT COMPLETED | Group B (7 Day Dosing) | 19 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Group A | 6 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Group B (3 Day Dosing) | 18 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | Group B (7 Day Dosing) | 20 | 61 | |
| other | Nausea | Gastrointestinal disorders | Group A | 3 | 27 | |
| other | Nausea | Gastrointestinal disorders | Group B (3 Day Dosing) | 16 | 62 | |
| other | Nausea | Gastrointestinal disorders | Group B (7 Day Dosing) | 7 | 61 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Group A | 0 | 27 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Group B (3 Day Dosing) | 3 | 62 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Group B (7 Day Dosing) | 4 | 61 | |
| other | Constipation | Gastrointestinal disorders | Group A | 0 | 27 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 0 | 27 |
| Total, all-cause mortality | Group B (3 Day Dosing) | 0 | 62 |
| Total, all-cause mortality | Group B (7 Day Dosing) | 0 | 61 |
| Total, other adverse events | Group A | 12 | 27 |
| Total, other adverse events | Group B (3 Day Dosing) | 35 | 62 |
| Total, other adverse events | Group B (7 Day Dosing) | 39 | 61 |
| Total, serious adverse events | Group A | 0 | 27 |
| Total, serious adverse events | Group B (3 Day Dosing) | 0 | 62 |
| Total, serious adverse events | Group B (7 Day Dosing) | 0 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05399641
GET https://conductscience.org/api/trials/v1/NCT05399641/results?page=2