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

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).

Sponsors

Lead Sponsor: Scynexis, Inc.

Collaborator: PPD

Source Scynexis, Inc.
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

Overall Status Active, not recruiting
Start Date June 7, 2019
Completion Date April 2020
Primary Completion Date March 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical cure (complete resolution of signs and symptoms) Day 8-14
Secondary Outcome
Measure Time Frame
Mycological eradication (negative culture for growth of yeast) Day 8-14
Clinical cure and mycological eradication (responder outcome) Day 8-14
Complete resolution of signs and symptoms at follow-up Day 25
Safety and tolerability of Ibrexafungerp Up to 29 Days
Enrollment 366
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ibrexafungerp

Description: Ibrexafungerp 300mg BID for one day

Arm Group Label: Ibrexafungerp (SCY-078)

Other Name: SCY-078

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching Placebo

Arm Group Label: Placebo

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.

Gender: Female

Gender Based: Yes

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Mesa OB-GYN | Mesa, Arizona, 85209, United States
Red Rocks OBGYN | Lakewood, Colorado, 80228, United States
Planned Parenthood Southern New England | New Haven, Connecticut, 06511, United States
New Generation Medical Research | Hialeah, Florida, 33016, United States
Healthcare Clinical Data Inc | North Miami, Florida, 33161, United States
Physician Care Clinical Research LLC | Sarasota, Florida, 34239, United States
CCT LLC - A VitaLink Company- PPDS | West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Research, LLC | Sandy Springs, Georgia, 30328, United States
Fellows Research Alliance Inc | Savannah, Georgia, 31406, United States
Rosemark Women Care Specialists | Idaho Falls, Idaho, 83404, United States
Praetorian Pharmaceutical Research, LLC | Marrero, Louisiana, 70072, United States
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri | Florissant, Missouri, 63033, United States
Clinical Research Center Of Nevada | Las Vegas, Nevada, 89123, United States
Planned Parenthood North Central Southern New Jersey (PPNCSNJ) | Hackensack, New Jersey, 07601, United States
Carolina Institute for Clinical Research - M3 Wake Research | Fayetteville, North Carolina, 28304, United States
Obstetrics and Gynecology Associates of Erie, PC | Erie, Pennsylvania, 16507, United States
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center | Philadelphia, Pennsylvania, 19107, United States
Fellows Research Alliance Inc | Bluffton, South Carolina, 29910, United States
Chattanooga Medical Research Inc | Chattanooga, Tennessee, 37404, United States
Signature GYN Services, PLLC | Fort Worth, Texas, 76104, United States
Brownstone Clinical Trials, LLC | Irving, Texas, 75062, United States
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD | Asenovgrad, 4230, Bulgaria
MHAT Puls AD - PPDS | Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital for Active Treatment - Chirpan EOOD | Chirpan, 6200, Bulgaria
Medical Center Asklepii OOD | Dupnitsa, 2600, Bulgaria
Diagnostic-Consultative Center I-Gabrovo EOOD | Gabrovo, 5300, Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova | Gabrovo, 5300, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD | Gorna Oryahovitsa, 5100, Bulgaria
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD | Lom, 3600, Bulgaria
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD | Lovech, 5500, Bulgaria
MHAT Stamen Iliev AD | Montana, 3400, Bulgaria
Multiprofile Hospital For Active Treatment - Pazardzhik AD | Pazardzhik, 4400, Bulgaria
Multiprofile Hospital for Active Treatment Trimontsium OOD | Plovdiv, 4000, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov, 2000, Bulgaria
Medical Center-1-Sevlievo EOOD | Sevlievo, 5400, Bulgaria
Multiprofile Hospital for Active Treatment Shumen | Shumen, 9700, Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD | Smolyan, 4700, Bulgaria
Medical Center Excelsior OOD - PPDS | Sofia, 1407, Bulgaria
Diagnostic Consultative CTR - XX - Sofia - EOOD | Sofia, 1618, Bulgaria
Medical center Vip Clinic OOD | Sofia, 1680, Bulgaria
Medical Center Medica Plus OOD | Veliko Tarnovo, 5000, Bulgaria
Location Countries

Bulgaria

United States

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ibrexafungerp (SCY-078)

Type: Experimental

Description: 300 mg BID for one day

Label: Placebo

Type: Placebo Comparator

Description: Matching Placebo

Acronym Vanish 306
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, placebo-controlled, double-blind study

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov