Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

Candida Vulvovaginitis Clinical Trial

— Vanish 306  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987620
• Other study ID #: SCY-078-306
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2019
• Est. completion date: April 29, 2020

Study information

• Verified date: August 2021
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: April 29, 2020
• Est. primary completion date: March 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candida Vulvovaginitis
• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginitis

Intervention

Drug:
• Ibrexafungerp
Ibrexafungerp 300mg BID for one day
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Treatment -Asenovgrad EOOD	Asenovgrad
Bulgaria	MHAT Puls AD - PPDS	Blagoevgrad
Bulgaria	Multiprofile Hospital for Active Treatment - Chirpan EOOD	Chirpan
Bulgaria	Medical Center Asklepii OOD	Dupnitsa
Bulgaria	Diagnostic-Consultative Center I-Gabrovo EOOD	Gabrovo
Bulgaria	Multiprofile Hospital For Active Treatment Dr Tota Venkova	Gabrovo
Bulgaria	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD	Gorna Oryahovitsa
Bulgaria	Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD	Lom
Bulgaria	Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD	Lovech
Bulgaria	MHAT Stamen Iliev AD	Montana
Bulgaria	Multiprofile Hospital For Active Treatment - Pazardzhik AD	Pazardzhik
Bulgaria	Multiprofile Hospital for Active Treatment Trimontsium OOD	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment - Samokov EOOD	Samokov
Bulgaria	Medical Center-1-Sevlievo EOOD	Sevlievo
Bulgaria	Multiprofile Hospital for Active Treatment Shumen	Shumen
Bulgaria	Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD	Smolyan
Bulgaria	Diagnostic Consultative CTR - XX - Sofia - EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD - PPDS	Sofia
Bulgaria	Medical center Vip Clinic OOD	Sofia
Bulgaria	Medical Center Medica Plus OOD	Veliko Tarnovo
United States	Fellows Research Alliance Inc	Bluffton	South Carolina
United States	Chattanooga Medical Research Inc	Chattanooga	Tennessee
United States	Obstetrics and Gynecology Associates of Erie, PC	Erie	Pennsylvania
United States	Carolina Institute for Clinical Research - M3 Wake Research	Fayetteville	North Carolina
United States	North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri	Florissant	Missouri
United States	Signature GYN Services, PLLC	Fort Worth	Texas
United States	Planned Parenthood North Central Southern New Jersey (PPNCSNJ)	Hackensack	New Jersey
United States	New Generation Medical Research	Hialeah	Florida
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Brownstone Clinical Trials, LLC	Irving	Texas
United States	Red Rocks OBGYN	Lakewood	Colorado
United States	Clinical Research Center Of Nevada	Las Vegas	Nevada
United States	Praetorian Pharmaceutical Research, LLC	Marrero	Louisiana
United States	Mesa OB-GYN	Mesa	Arizona
United States	Planned Parenthood Southern New England	New Haven	Connecticut
United States	Healthcare Clinical Data Inc	North Miami	Florida
United States	Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center	Philadelphia	Pennsylvania
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Physician Care Clinical Research LLC	Sarasota	Florida
United States	Fellows Research Alliance Inc	Savannah	Georgia
United States	CCT LLC - A VitaLink Company- PPDS	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure (Complete Resolution of Signs and Symptoms)	The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit	Day 8-14
Secondary	Mycological Eradication (Negative Culture for Growth of Yeast)	The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit	Day 8-14
Secondary	Clinical Cure and Mycological Eradication (Responder Outcome)	The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit	Day 8-14
Secondary	Complete Clinical Response at Follow-up	The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit	Day 25
Secondary	Safety and Tolerability of Ibrexafungerp	Number of subjects with treatment related adverse events	Up to 29 Days