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Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03734991
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Candida Vulvovaginitis Drug: Ibrexafungerp Drug: Placebo Phase 3

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 for 1 day
  • Oral ibrexafungerp matching placebo BID for 1 day

Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.

All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, placebo-controlled, double-blind study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : August 21, 2019
Actual Study Completion Date : September 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Ibrexafungerp (SCY-078)
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Drug: Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Other Name: SCY-078

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. Clinical Cure (Complete Resolution of Signs and Symptoms) [ Time Frame: Day 8-14 ]
    measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit

Secondary Outcome Measures :
  1. Mycological Eradication (Negative Culture for Growth of Yeast) [ Time Frame: Day 8-14 ]
    percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit

  2. Clinical Cure and Mycological Eradication (Responder Outcome) [ Time Frame: Day 8-14 ]
    percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit

  3. Complete Clinical Response at Follow-Up [ Time Frame: Day 25 ]
    percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit

  4. Overall Treatment-Emergent Adverse Events (Safety Set) [ Time Frame: Up to 29 days ]
    Number of subjects with treatment related adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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% 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) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization

Subject is actively menstruating at the time of the Baseline visit.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03734991

Show Show 25 study locations
Sponsors and Collaborators
Scynexis, Inc.
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Study Director: David Angulo, MD Scynexis, Inc.
  Study Documents (Full-Text)

Documents provided by Scynexis, Inc.:
Study Protocol  [PDF] October 12, 2018
Statistical Analysis Plan  [PDF] October 16, 2019

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Scynexis, Inc. Identifier: NCT03734991    
Other Study ID Numbers: SCY-078-303
First Posted: November 8, 2018    Key Record Dates
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis, Vulvovaginal
Bacterial Infections and Mycoses
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Vulvar Diseases
Genital Diseases
Antifungal Agents
Anti-Infective Agents