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Trial record 2 of 9 for:    scynexis

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

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ClinicalTrials.gov Identifier: NCT03734991
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 14, 2018
Sponsor:
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 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
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Ibrexafungerp (SCY-078)
300 mg dose BID for day
Drug: Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Other Name: SCY-078

Placebo Comparator: Placebo
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 resolution of signs and symptoms at follow-up [ Time Frame: Day 25 ]
    percentage of subjects with complete resolution of symptoms at the Follow-up (FU) visit

  4. Number of subjects with treatment related adverse events [ Time Frame: Up to 29 days ]


Information from the National Library of Medicine

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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% 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 ClinicalTrials.gov identifier (NCT number): NCT03734991


Contacts
Contact: Rebecca F Cadet 201 884-5477 ext 5477 rebecca.cadet@scynexis.com
Contact: David Angulo, MD 786 942-3854 david.angulo@scynexis.com

Sponsors and Collaborators
Scynexis, Inc.
Investigators
Study Director: David Angulo, MD Scynexis, Inc.

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03734991     History of Changes
Other Study ID Numbers: SCY-078-303
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Vulvovaginitis
Mycoses
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases