CompletedPhase 3

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

United States150 participantsStarted 2022-05-01

Plain-language 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.

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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).
✓. 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

✕. 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.
✕. 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 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.

Clinical Cure

Timeframe: 14 days post-Baseline - Test-Of-Cure (TOC)

NCT IDNCT05399641

SponsorScynexis, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-16

Results submitted2024-06-05

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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).
✓. 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

✕. 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.
✕. 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 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.