Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) (CANDLE)

Scynexis

Status and phase: Completed; Phase 3

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: Placebo oral tablet; Drug: IBREXAFUNGERP; Drug: Fluconazole Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04029116

SCY-078-304

Details and patient eligibility

About

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Full description

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.

Enrollment: 440 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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440 participants in 2 patient groups, including a placebo group

Ibrexafungerp

Experimental group

Description:

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

Treatment:

Drug: IBREXAFUNGERP

Drug: Fluconazole Tablet

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet

Drug: Fluconazole Tablet