Clinical trial NCT03253094: Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candida Vulvovaginitis
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, double-dummy, active-controlled, dose-finding
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Clinical Cure (Complete Resolution of Signs and Symptoms)
timeFrame: 8-12 days
Secondary outcomes:
measure: Co-occurrence of Clinical and Mycological Cure
timeFrame: 29 days
Other outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: up to 29 days
Locations:
city: Birmingham
country: United States
facility: UAB Personal Health Clinic
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: San Diego
country: United States
facility: Women's Health Care Research Corp.
state: California
city: Brandon
country: United States
facility: Gulf Coast Research Group, LLC
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida P.A.
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corp.
state: Florida
city: South Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Roswell
country: United States
facility: Atlanta North Gynecology, P.C.
state: Georgia
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: Covington
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC
state: Louisiana
city: Detroit
country: United States
facility: Tolan Park Medical Building
state: Michigan
city: Saint Louis
country: United States
facility: Consultants in Women's Healthcare, Inc.
state: Missouri
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Clinical Research, LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Greensboro
country: United States
facility: Unified Women's Clinical Research - Central Carolina
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis, LLC
state: Tennessee
city: Houston
country: United States
facility: Tmc Life Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology
state: Washington
Study officials:
affiliation: Scynexis, Inc.
name: David Angulo, MD
role: STUDY_DIRECTOR
References:
citation: Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.