Vulvovaginal CandidiasisPhase 2NCT02679456
Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
A Phase 2 study testing SCY-078 and Fluconazole in people with Vulvovaginal Candidiasis, run by Scynexis, Inc. at 2 sites in Dominican Republic.
Trial summary
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- SCY-078 and Fluconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesDominican Republic
- Study dates
- Nov 2015to 5 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must fulfill all of the following criteria to be eligible for study admission:
- Female subjects from 18 to 65 years of age in good general health
- Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
- The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
- The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
- The ability to understand and follow all study-related procedures including study drug administration.
- Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Who cannot join
- A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:
- Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
- Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.
- Subjects with history of renal impairment, hepatic impairment or cervical cancer.
- 4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
- 5. HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.
Trial locations and contacts
2 sites in 1 country.
Dominican Republic2 sites
Hospital Dr. Francisco E. Moscoso Puello
Santo Domingo
Instituto Dermatologico y Cirugia de Piel
Santo Domingo
About this study
Official title: A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Read the detailed description
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Primary Objectives:
- To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
- To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- SCY-078, Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCY-078Drug
FluconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 (Fluconazole) | Active comparator | Fluconazole Receives: Drug: Fluconazole |
| Treatment Group 2: (SCY-078) | Experimental | Dose regimen 1 Receives: Drug: SCY-078 |
| Treatment Group 3 (SCY-078) | Experimental | Dose regimen 2 Receives: Drug: SCY-078 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)
Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).
Measured: Day 24 +/- 3
Secondary outcomes (1)
Proportion of subjects with recurrence of VVC during the observation period
Recurrence defined as a symptomatic and culture-verified episode of VVC after achieving Therapeutic Cure.
Measured: 4-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startNov 2015
- Primary completion5 Aug 2016
- Study completion5 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
- Investigators
- David Angulo, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679456
- Sponsor's protocol ID
- SCY-078-203
- Status last verified
- Jul 2019
- First submitted
- 19 Jan 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT02679456
- Acronym / sponsor ID
- SCY-078-203
- Conditions
- Vulvovaginal Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- Nov 2015
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Detailed description
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
Primary Objectives:
- To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)
Secondary Objectives:
- To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 (Fluconazole) | Active comparator | Drug: FluconazoleFluconazole |
| Treatment Group 2: (SCY-078) | Experimental | Drug: SCY-078Dose regimen 1 |
| Treatment Group 3 (SCY-078) | Experimental | Drug: SCY-078Dose regimen 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female subjects from 18 to 65 years of age in good general health
- Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
- The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
- The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
- The ability to understand and follow all study-related procedures including study drug administration.
Key exclusion criteria (7 listed)
- A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:
- Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:
- Subjects with history of renal impairment, hepatic impairment or cervical cancer.
- 4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCY-078 | Drug | Treatment Group 2: (SCY-078), Treatment Group 3 (SCY-078) |
| Fluconazole | Drug | Treatment Group 1 (Fluconazole) |
Primary outcome
Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)
Time frame: Day 24 +/- 3
Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).
1 secondary outcome
Proportion of subjects with recurrence of VVC during the observation period
Time frame: 4-month observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Vulvovaginal Candidiasis
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
Vulvovaginal Candidiasis
Active, not recruitingObservational study
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Vulvovaginal Candidiasis
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Angulo, MD study director
Scynexis, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCY-078 and Fluconazole in people with Vulvovaginal Candidiasis, run by Scynexis, Inc. at 2 sites in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3) (time frame: Day 24 +/- 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.