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Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)

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.
 
ClinicalTrials.gov Identifier: NCT03987620
Recruitment Status : Completed
First Posted : June 17, 2019
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

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

  4. Safety and Tolerability of Ibrexafungerp [ Time Frame: Up to 29 Days ]
    Number of subjects with treatment related adverse events


Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT03987620


Locations
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Sponsors and Collaborators
Scynexis, Inc.
  Study Documents (Full-Text)

Documents provided by Scynexis, Inc.:
Study Protocol  [PDF] November 20, 2018
Statistical Analysis Plan  [PDF] March 24, 2020

More Information
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Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03987620    
Other Study ID Numbers: SCY-078-306
First Posted: June 17, 2019    Key Record Dates
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scynexis, Inc.:
Vaginitis
Yeast infection
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Vulvovaginitis
Mycoses
Bacterial Infections and Mycoses
Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Vulvitis
Vulvar Diseases
Genital Diseases
Ibrexafungerp
Antifungal Agents
Anti-Infective Agents