Vulvovaginal CandidiasisPhase 3NCT05399641
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
A Phase 3 study testing Ibrexafungerp in people with Vulvovaginal Candidiasis, run by Scynexis, Inc. at 25 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Ibrexafungerp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 May 2022to 2 Aug 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
- Normal vaginal pH (≤ 4.5).
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- Has no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).
- Subject should also have:
- 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
- A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR
- 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
- A VVC episode caused by Candida species with documented resistance to fluconazole based on MIC determination. OR
- 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 childbearing potential < 1 year post-menopausal must agree to and comply with using one barrier method (male condom, female condom, and diaphragm) plus one other highly effective method of birth control, 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.
Who cannot join
- 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.
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- Subject has a known hypersensitivity to any of the components of the formulation.
- Subject has participated in any other investigational 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Wake (Mount Vernon Clinical Research)
Atlanta, Georgia, 30328
Massachusetts's General
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Discovery Clinical Trials
Dallas, Texas, 75230
Wayne State University
Detroit, Michigan, 48201
Wake Research (Carolina Institute for Clinical Research)
Fayetteville, North Carolina, 28303
TMC Life Research, Inc
Houston, Texas, 77054
Clinical Research Prime
Idaho Falls, Idaho, 83404
Leavitt Women's Healthcare
Idaho Falls, Idaho, 83404
Center for Colposcopy
Lake Success, New York, 11042
Wake Research (CRCN)
Las Vegas, Nevada, 89123
Capital Health Lawrence OBGYN
Lawrenceville, New Jersey, 08648
Discovery Clinical Trials
McAllen, Texas, 78503
Medical Research Center
Memphis, Tennessee, 38120
New Age Medical Research
Miami, Florida, 33186
Women Under Study
New Orleans, Louisiana, 70125
Jefferson University
Philadelphia, Pennsylvania, 19107
Precision Trials, AZ
Phoenix, Arizona, 85032
Oregon Health and Science University
Portland, Oregon, 97239
UWCR - Raleigh
Raleigh, North Carolina, 27607
Women's Healthcare Research
San Diego, California, 92111
Wake Research (MCCR)
San Diego, California, 92120
Seattle Clinical Research Center
Seattle, Washington, 98105
Consultants in Women's Healthcare
St Louis, Missouri, 63131
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy
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
- Vulvovaginal Candidiasis
- Being tested
- Ibrexafungerp
- Keywords
- vulvovaginal candidiasis, candida, VVC, rVVC, Ibrexafungerp, yeast vaginitis
- Medical subject headings
- Candidiasis, Vulvovaginal, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrexafungerpDrug
Each day dosing will consist of two 150mg tablets taken BID.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Ibrexafungerp |
| Group B (3 Day dosing) | Experimental | 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. Receives: Drug: Ibrexafungerp |
| Group B (7 Day dosing) | Experimental | 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 Receives: Drug: Ibrexafungerp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days post-Baseline - Test-Of-Cure (TOC)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 May 2022
- Primary completion16 May 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, 3 group, stratified
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Tierney, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399641
- Sponsor's protocol ID
- SCY-078-307b
- Status last verified
- Jul 2024
- First submitted
- 23 May 2022
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy
- ClinicalTrials.gov ID
- NCT05399641
- Acronym / sponsor ID
- SCY-078-307b
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- vulvovaginal candidiasis, candida, VVC, rVVC, Ibrexafungerp, yeast vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, 3 group, stratified
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: IbrexafungerpSubjects 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. |
| Group B (3 Day dosing) | Experimental | Drug: IbrexafungerpSubjects 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. |
| Group B (7 Day dosing) | Experimental | Drug: IbrexafungerpSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Subject should also have:
- Subject is able to take oral tablets.
- Subject is not pregnant or lactating and plans not to become pregnant. Women of childbearing potential < 1 year post-menopausal must agree to and comply with using one barrier method (male condom, female condom, and diaphragm) plus one other highly effective method of birth control, 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrexafungerpEach day dosing will consist of two 150mg tablets taken BID. | Drug | Group A, Group B (3 Day dosing), Group B (7 Day dosing) |
Primary outcome
Clinical Cure
Time frame: 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.
7 secondary outcomes
Clinical Improvement
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
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
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
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
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
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
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Tierney study director
Scynexis, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibrexafungerp in people with Vulvovaginal Candidiasis, run by Scynexis, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: 14 days post-Baseline - Test-Of-Cure (TOC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.