NCT05399641

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	Each day dosing will consist of two 150mg tablets taken BID.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-16
• Completion: 2023-08-02
• First posted: 2022-06-01
• Last updated: 2024-07-10
• Results posted: 2024-07-10

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study