Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (CANDLE)
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ClinicalTrials.gov Identifier: NCT04029116 |
Recruitment Status :
Completed
First Posted : July 23, 2019
Last Update Posted : April 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Recurrent Vulvovaginal Candidiasis | Drug: Fluconazole Tablet Drug: IBREXAFUNGERP Drug: Placebo oral tablet | Phase 3 |
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.
Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Open label (acute phase treatment) followed by Randomized, Double Blinded phase |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) |
Actual Study Start Date : | October 21, 2019 |
Actual Primary Completion Date : | September 1, 2021 |
Actual Study Completion Date : | November 29, 2021 |

Arm | Intervention/treatment |
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Experimental: Ibrexafungerp
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
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Drug: Fluconazole Tablet
150 mg every 72 hours for 3 doses Drug: IBREXAFUNGERP 300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Other Name: SCY-078 |
Placebo Comparator: Placebo
Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days
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Drug: Fluconazole Tablet
150 mg every 72 hours for 3 doses Drug: Placebo oral tablet BID (one day) every 4 weeks for a total of 6 dosing days |
- Clinical Success [ Time Frame: Week 24 ]Efficacy as measured by the percentage of subjects with documented Clinical Success.
- The percentage of subjects with no Mycologically Proven Recurrence [ Time Frame: Week 24 and Week 36 ]Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
- Safety and tolerability [ Time Frame: Week 24 ]Safety as measured by the number of subjects who discontinue due to treatment related adverse events.

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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 |
Key Inclusion Criteria:
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- History of 3 or more episodes of VVC in the past 12 months.
- Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- Able to take oral tablets and capsules.
Key exclusion Criteria:
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.

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 ClinicalTrials.gov identifier (NCT number): NCT04029116

Study Director: | Nkechi Azie, MD | Scynexis, Inc. |
Responsible Party: | Scynexis, Inc. |
ClinicalTrials.gov Identifier: | NCT04029116 |
Other Study ID Numbers: |
SCY-078-304 |
First Posted: | July 23, 2019 Key Record Dates |
Last Update Posted: | April 18, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Recurrent yeast infection Recurrent yeast vaginitis Chronic yeast vaginitis |
Ibrexafungerp SCY-078 RVVC |
Candidiasis Candidiasis, Vulvovaginal Recurrence Disease Attributes Pathologic Processes Mycoses Bacterial Infections and Mycoses Infections Vulvovaginitis Vaginitis Vaginal Diseases Vulvitis Vulvar Diseases Fluconazole |
Ibrexafungerp Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors |