Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (DOVE)

Scynexis

Status and phase: Completed; Phase 2

Conditions: Candida Vulvovaginitis

Treatments: Drug: SCY-078; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03253094

SCY-078-204

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

Full description

This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Enrollment: 186 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Subject is a female of at least 18 years of age
2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Key Exclusion Criteria:

1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
3. Subject is actively menstruating at the time of the Baseline visit.
4. Subject has uncontrolled diabetes mellitus.
5. Subject has a vaginal sample with pH >4.5.
6. Subject has a history of or an active cervical/vaginal cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

186 participants in 6 patient groups

Fluconazole

Active Comparator group

Description:

150 mg/day for 1 day

Treatment:

Drug: Fluconazole

Ibrexafungerp 750mg

Experimental group

Description:

750mg QD for 1 day only

Treatment:

Drug: SCY-078

Ibrexafungerp 300mg

Experimental group

Description:

300mg BID for 1 day only

Treatment:

Drug: SCY-078

Ibrexafungerp 450mg

Experimental group

Description:

450mg BID for 1 day only

Treatment:

Drug: SCY-078

Ibrexafungerp 150mg

Experimental group

Description:

150mg BID for 3 days

Treatment:

Drug: SCY-078

Ibrexafungerp 300mg D1-D3

Experimental group

Description:

300mg BID for 3 days

Treatment:

Drug: SCY-078