Recurrent Vulvovaginal CandidiasisPhase 3CANDLENCT04029116
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
A Phase 3 study testing Fluconazole Tablet and IBREXAFUNGERP in people with Recurrent Vulvovaginal Candidiasis, run by Scynexis, Inc. at 25 sites in United States.
Trial summary
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC). Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- Fluconazole Tablet and IBREXAFUNGERP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 25 sitesUnited States
- Study dates
- 21 Oct 2019to 29 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- History of 3 or more episodes of VVC in the past 12 months.
- Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- Able to take oral tablets and capsules.
Who cannot join
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Bosque Women's Care
Albuquerque, New Mexico, 87109
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404
Cleveland Clinic
Cleveland, Ohio, 44195
Clinical Trials Management
Covington, Louisiana, 70433
Wayne State University
Detroit, Michigan, 48201
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, 16507
Unified Womens CLinical Research
Greensboro, North Carolina, 27408
Unified Women's Clinical Research
Hagerstown, Maryland, 21740
TMC Life Research Inc
Houston, Texas, 77054
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, 83404
Altus Research - Hunt - PPDS
Lake Worth, Florida, 33461
Center For Women's Health and Wellness LLC
Lawrenceville, New Jersey, 08648
Lawrence Obstetrics Gynecology Clinical Research LLC
Lawrenceville, New Jersey, 08648
Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120
New Age Medical Research Corporation
Miami, Florida, 33186
Women Under Study, LLC
New Orleans, Louisiana, 70125
Healthcare Clinical Data Inc
North Miami, Florida, 33161
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Precision Trials LLC
Phoenix, Arizona, 85032
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Women's Healthcare Research Corp
San Diego, California, 92111
Group For Women
Winston-Salem, North Carolina, 27103
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
Read the detailed description
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.
Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- Fluconazole Tablet, IBREXAFUNGERP, Placebo oral tablet
- Keywords
- Recurrent yeast infection, Recurrent yeast vaginitis, Chronic yeast vaginitis, Ibrexafungerp, SCY-078, RVVC
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole TabletDrug
150 mg every 72 hours for 3 doses
IBREXAFUNGERPDrug
Also called SCY-078
300 mg BID (one day) every 4 weeks for a total of 6 dosing days
Placebo oral tabletDrug
BID (one day) every 4 weeks for a total of 6 dosing days
| Study group | Role | What they receive |
|---|---|---|
| Ibrexafungerp | Experimental | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days Receives: Drug: Fluconazole Tablet; Drug: IBREXAFUNGERP |
| Placebo | Placebo comparator | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days Receives: Drug: Fluconazole Tablet; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Efficacy as measured by the percentage of subjects with documented Clinical Success.
Measured: Week 24
Secondary outcomes (2)
The Percentage of Subjects With no Mycologically Proven Recurrence
Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence
Measured: Week 24
Safety and Tolerability
Safety as measured by the number of subjects who discontinue due to treatment related adverse events.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start21 Oct 2019
- Primary completion1 Sep 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label (acute phase treatment) followed by Randomized, Double Blinded phase
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nkechi Azie, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029116
- Sponsor's protocol ID
- SCY-078-304
- Acronym
- CANDLE
- Status last verified
- May 2023
- First submitted
- 19 Jul 2019
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT04029116
- Acronym / sponsor ID
- CANDLE / SCY-078-304
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Keywords
- Recurrent yeast infection, Recurrent yeast vaginitis, Chronic yeast vaginitis, Ibrexafungerp, SCY-078, RVVC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).
Detailed description
This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.
Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Open label (acute phase treatment) followed by Randomized, Double Blinded phase
| Arm | Type | Receives |
|---|---|---|
| Ibrexafungerp | Experimental | Drug: Fluconazole Tablet, Drug: IBREXAFUNGERPOral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
| Placebo | Placebo comparator | Drug: Fluconazole Tablet, Drug: Placebo oral tabletOral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
- History of 3 or more episodes of VVC in the past 12 months.
- Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
- Able to take oral tablets and capsules.
Key exclusion criteria (4 listed)
- Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
- Recent use of systemic and/or topical vaginal antifungal products.
- Pregnant.
- History of major system organ disease.
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 |
|---|---|---|
| Fluconazole Tablet150 mg every 72 hours for 3 doses | Drug | Ibrexafungerp, Placebo |
| IBREXAFUNGERPAlso: SCY-078300 mg BID (one day) every 4 weeks for a total of 6 dosing days | Drug | Ibrexafungerp |
| Placebo oral tabletBID (one day) every 4 weeks for a total of 6 dosing days | Drug | Placebo |
Primary outcome
Clinical Success
Time frame: Week 24
Efficacy as measured by the percentage of subjects with documented Clinical Success.
2 secondary outcomes
The Percentage of Subjects With no Mycologically Proven Recurrence
Time frame: Week 24
Safety and Tolerability
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nkechi Azie, MD study director
Scynexis, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluconazole Tablet and IBREXAFUNGERP in people with Recurrent Vulvovaginal Candidiasis, run by Scynexis, Inc. at 25 sites in United States.
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 4 inclusion and 4 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success (time frame: Week 24). 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 18 Jun 2023.