Clinical trial NCT03987620: Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candida Vulvovaginitis
Keywords: Vaginitis
Yeast infection
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 455
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blind study
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Detailed description: Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:

* Oral ibrexafungerp 300-mg dose BID (bis in die) for 1 day
* Oral ibrexafungerp matching placebo BID for 1 day

This is a randomized, double-blind study.

Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991

Eligibility criteria: Inclusion Criteria:

* Subject is a postmenarchal female subject 12 years and older
* Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Exclusion Criteria:

* 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)
* Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
* Subject has uncontrolled diabetes mellitus.
* Subject has a vaginal sample with pH \>4.5.
* Subject has a history of or an active cervical/vaginal cancer.

Primary outcomes:
measure: Clinical Cure (Complete Resolution of Signs and Symptoms)
timeFrame: Day 8-14
Secondary outcomes:
measure: Mycological Eradication (Negative Culture for Growth of Yeast)
timeFrame: Day 8-14
measure: Clinical Cure and Mycological Eradication (Responder Outcome)
timeFrame: Day 8-14
measure: Complete Clinical Response at Follow-up
timeFrame: Day 25
measure: Safety and Tolerability of Ibrexafungerp
timeFrame: Up to 29 Days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Mesa OB-GYN
state: Arizona
city: Lakewood
country: United States
facility: Red Rocks OBGYN
state: Colorado
city: New Haven
country: United States
facility: Planned Parenthood Southern New England
state: Connecticut
city: Hialeah
country: United States
facility: New Generation Medical Research
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data Inc
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC
state: Florida
city: West Palm Beach
country: United States
facility: CCT LLC - A VitaLink Company- PPDS
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance Inc
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research, LLC
state: Louisiana
city: Florissant
country: United States
facility: North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center Of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
state: New Jersey
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research - M3 Wake Research
state: North Carolina
city: Erie
country: United States
facility: Obstetrics and Gynecology Associates of Erie, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
state: Pennsylvania
city: Bluffton
country: United States
facility: Fellows Research Alliance Inc
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research Inc
state: Tennessee
city: Fort Worth
country: United States
facility: Signature GYN Services, PLLC
state: Texas
city: Irving
country: United States
facility: Brownstone Clinical Trials, LLC
state: Texas
city: Asenovgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
city: Blagoevgrad
country: Bulgaria
facility: MHAT Puls AD - PPDS
city: Chirpan
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Chirpan EOOD
city: Dupnitsa
country: Bulgaria
facility: Medical Center Asklepii OOD
city: Gabrovo
country: Bulgaria
facility: Diagnostic-Consultative Center I-Gabrovo EOOD
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Dr Tota Venkova
city: Gorna Oryahovitsa
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
city: Lom
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
city: Lovech
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
city: Montana
country: Bulgaria
facility: MHAT Stamen Iliev AD
city: Pazardzhik
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Pazardzhik AD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Trimontsium OOD
city: Samokov
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Samokov EOOD
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Shumen
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Shumen
city: Smolyan
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative CTR - XX - Sofia - EOOD
city: Sofia
country: Bulgaria
facility: Medical center Vip Clinic OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Medica Plus OOD
Study officials:
References: