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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03734991
Other study ID # SCY-078-303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 4, 2019
Est. completion date September 4, 2019

Study information

Verified date August 2021
Source Scynexis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 376
Est. completion date September 4, 2019
Est. primary completion date August 21, 2019
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Ibrexafungerp
Ibrexafungerp 300 mg BID for 1 day
Placebo
Matching placebo

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Medical Research South Charleston South Carolina
United States Women's Medical Research Group Clearwater Florida
United States Clinical Trials Management LLC Covington Louisiana
United States Wayne State University Detroit Michigan
United States Carolina Women's Research and Wellness Center Durham North Carolina
United States GYN Center for Women PA Durham North Carolina
United States Unified Women's Clinical Research Greensboro Greensboro North Carolina
United States Unified Women's Clinical Research- Hagerstown Hagerstown Maryland
United States TMC Life Research Inc Houston Texas
United States Altus Research Lake Worth Florida
United States Center For Women's Health and Wellness LLC - Interspond - PPDS Lawrenceville New Jersey
United States Lawrence OB/GYN Clinical Research, LLC Lawrenceville New Jersey
United States OBGYN Assoc of Mid Florida Leesburg Florida
United States Medical Research Center of Memphis Memphis Tennessee
United States Clinical Trials Management LLC Metairie Louisiana
United States New Age Medical Research Corporation Miami Florida
United States Unified Women's Clinical Research Morehead City North Carolina
United States Magnolia Ob/Gyn Research Center, LLC Myrtle Beach South Carolina
United States Group For Women Norfolk Virginia
United States Precision Trials AZ, LLC Phoenix Arizona
United States Unified Women's Clinical Research Raleigh Raleigh North Carolina
United States Consultants In Women's Healthcare, Inc. Saint Louis Missouri
United States Womens' Health Care Research Corp San Diego California
United States Unified Women's Clinical Research - Lyndhurst Clinical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Scynexis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Cure (Complete Resolution of Signs and Symptoms) measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit Day 8-14
Secondary Mycological Eradication (Negative Culture for Growth of Yeast) percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit Day 8-14
Secondary Clinical Cure and Mycological Eradication (Responder Outcome) percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit Day 8-14
Secondary Complete Clinical Response at Follow-Up percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit Day 25
Secondary Overall Treatment-Emergent Adverse Events (Safety Set) Number of subjects with treatment related adverse events Up to 29 days
See also
  Status Clinical Trial Phase
Completed NCT03987620 - Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis Phase 3
Recruiting NCT04219605 - Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Completed NCT03253094 - Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Phase 2