Working… Menu

An Active-Controlled, Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (DOVE)

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. Identifier: NCT03253094
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : October 27, 2020
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

Condition or disease Intervention/treatment Phase
Candida Vulvovaginitis Drug: Fluconazole Drug: SCY-078 Phase 2

Detailed Description:
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, double-dummy, active-controlled, dose-finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Active Comparator: Fluconazole
150 mg/day for 1 day
Drug: Fluconazole
Other Name: Diflucan, Azole antifungal

Experimental: SCY-078
5 different active dosing groups with 2 different treatment regiments of either 1 or 3 days
Drug: SCY-078

Primary Outcome Measures :
  1. Clinical cure (complete resolution of signs and symptoms) [ Time Frame: 8-12 days ]
    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. Co-occurrence of clinical and mycological cure [ Time Frame: 29 days ]
    The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure and follow up visit.

Other Outcome Measures:
  1. Incidence of treatment emergent adverse events [ Time Frame: up to 29 days ]
    The number of subjects with treatment related adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Subject is a female of at least 18 years of age
  2. 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)

Key Exclusion Criteria:

  1. 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)
  2. 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
  3. Subject is actively menstruating at the time of the Baseline visit.
  4. Subject has uncontrolled diabetes mellitus.
  5. Subject has a vaginal sample with pH >4.5.
  6. 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 identifier (NCT number): NCT03253094

Show Show 25 study locations
Sponsors and Collaborators
Scynexis, Inc.
Layout table for investigator information
Study Director: David Angulo, MD Scynexis, Inc.
Layout table for additonal information
Responsible Party: Scynexis, Inc. Identifier: NCT03253094    
Other Study ID Numbers: SCY-078-204
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Candidiasis, Vulvovaginal
Vaginal Diseases
Vulvar Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors