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出境医 / 临床实验 / Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)
Study Description
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 (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
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 366 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, placebo-controlled, double-blind study |
| Masking: | Double (Participant, 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 (AVVC). |
| Actual Study Start Date : | June 7, 2019 |
| Actual Primary Completion Date : | March 29, 2020 |
| Actual Study Completion Date : | April 29, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Ibrexafungerp (SCY-078)
300 mg BID for one day
|
Drug: Ibrexafungerp
Ibrexafungerp 300mg BID for one day
Other Name: SCY-078
|
|
Placebo Comparator: Placebo
Matching Placebo
|
Drug: Placebo
Matching Placebo
|
Outcome Measures
Primary Outcome Measures :
- Clinical cure (complete resolution of signs and symptoms) [ Time Frame: Day 8-14 ]The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Secondary Outcome Measures :
- Mycological eradication (negative culture for growth of yeast) [ Time Frame: Day 8-14 ]The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
- Clinical cure and mycological eradication (responder outcome) [ Time Frame: Day 8-14 ]The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
- Complete resolution of signs and symptoms at follow-up [ Time Frame: Day 25 ]The percentage of subjects with complete resolution of symptoms at the Follow-up (FU) visit
- Safety and tolerability of Ibrexafungerp [ Time Frame: Up to 29 Days ]Number of subjects with treatment related adverse events
Eligibility Criteria
| 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 |
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.
Contacts and Locations
Locations
Show 41 study locations
Sponsors and Collaborators
Scynexis, Inc.
PPD
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 12, 2019 | ||||
| First Posted Date ICMJE | June 17, 2019 | ||||
| Last Update Posted Date | March 24, 2021 | ||||
| Actual Study Start Date ICMJE | June 7, 2019 | ||||
| Actual Primary Completion Date | March 29, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical cure (complete resolution of signs and symptoms) [ Time Frame: Day 8-14 ] The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis | ||||
| Official Title ICMJE | 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). | ||||
| 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:
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 |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, placebo-controlled, double-blind study Masking: Double (Participant, Investigator)Primary Purpose: Treatment |
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| Condition ICMJE | Candida Vulvovaginitis | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
366 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | April 29, 2020 | ||||
| Actual Primary Completion Date | March 29, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Bulgaria, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03987620 | ||||
| Other Study ID Numbers ICMJE | SCY-078-306 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Scynexis, Inc. | ||||
| Study Sponsor ICMJE | Scynexis, Inc. | ||||
| Collaborators ICMJE | PPD | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Scynexis, Inc. | ||||
| Verification Date | March 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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