Candida VulvovaginitisPhase 3Vanish 306NCT03987620
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
A Phase 3 study testing Ibrexafungerp in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 41 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Candida Vulvovaginitis
- What is being tested?
- Ibrexafungerp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 7 Jun 2019to 29 Apr 2020
- 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
- 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% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Who cannot join
- 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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
- 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.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States21 sites
Fellows Research Alliance Inc
Bluffton, South Carolina, 29910
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404
Obstetrics and Gynecology Associates of Erie, PC
Erie, Pennsylvania, 16507
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, 28304
North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri
Florissant, Missouri, 63033
Signature GYN Services, PLLC
Fort Worth, Texas, 76104
Planned Parenthood North Central Southern New Jersey (PPNCSNJ)
Hackensack, New Jersey, 07601
New Generation Medical Research
Hialeah, Florida, 33016
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Brownstone Clinical Trials, LLC
Irving, Texas, 75062
Red Rocks OBGYN
Lakewood, Colorado, 80228
Clinical Research Center Of Nevada
Las Vegas, Nevada, 89123
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
Mesa OB-GYN
Mesa, Arizona, 85209
Planned Parenthood Southern New England
New Haven, Connecticut, 06511
Healthcare Clinical Data Inc
North Miami, Florida, 33161
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, 19107
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Fellows Research Alliance Inc
Savannah, Georgia, 31406
CCT LLC - A VitaLink Company- PPDS
West Palm Beach, Florida, 33409
Bulgaria20 sites
Multiprofile Hospital for Active Treatment -Asenovgrad EOOD
Asenovgrad, 4230
MHAT Puls AD - PPDS
Blagoevgrad, 2700
Multiprofile Hospital for Active Treatment - Chirpan EOOD
Chirpan, 6200
Medical Center Asklepii OOD
Dupnitsa, 2600
Diagnostic-Consultative Center I-Gabrovo EOOD
Gabrovo, 5300
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, 5300
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Gorna Oryahovitsa EOOD
Gorna Oryahovitsa, 5100
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
Lom, 3600
Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
Lovech, 5500
MHAT Stamen Iliev AD
Montana, 3400
Multiprofile Hospital For Active Treatment - Pazardzhik AD
Pazardzhik, 4400
Multiprofile Hospital for Active Treatment Trimontsium OOD
Plovdiv, 4000
Multiprofile Hospital for Active Treatment - Samokov EOOD
Samokov, 2000
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400
Multiprofile Hospital for Active Treatment Shumen
Shumen, 9700
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, 4700
Medical Center Excelsior OOD - PPDS
Sofia, 1407
Diagnostic Consultative CTR - XX - Sofia - EOOD
Sofia, 1618
Medical center Vip Clinic OOD
Sofia, 1680
Medical Center Medica Plus OOD
Veliko Tarnovo, 5000
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) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
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.
Read the 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 (bis in die) for 1 day
- Oral ibrexafungerp matching placebo BID for 1 day
This is a randomized, double-blind study.
Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991
- Conditions
- Candida Vulvovaginitis
- Being tested
- Ibrexafungerp, Placebo
- Keywords
- Vaginitis, Yeast infection
- Medical subject headings
- Candidiasis, Vulvovaginal, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrexafungerpDrug
Also called SCY-078
Ibrexafungerp 300mg BID for one day
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | 300 mg BID for one day Receives: Drug: Ibrexafungerp |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure (Complete Resolution of Signs and Symptoms)
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Measured: Day 8-14
Secondary outcomes (4)
Mycological Eradication (Negative Culture for Growth of Yeast)
The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Measured: Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Measured: Day 8-14
Complete Clinical Response at Follow-up
The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Measured: Day 25
Safety and Tolerability of Ibrexafungerp
Number of subjects with treatment related adverse events
Measured: Up to 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start7 Jun 2019
- Primary completion29 Mar 2020
- Study completion29 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candida VulvovaginitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987620
- Sponsor's protocol ID
- SCY-078-306
- Acronym
- Vanish 306
- Status last verified
- Aug 2021
- First submitted
- 12 Jun 2019
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
PubMed 36255448
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. 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) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
- ClinicalTrials.gov ID
- NCT03987620
- Acronym / sponsor ID
- Vanish 306 / SCY-078-306
- Conditions
- Candida Vulvovaginitis
- Keywords
- Vaginitis, Yeast infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 29 Mar 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 8 Sep 2021
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 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.
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 (bis in die) for 1 day
- Oral ibrexafungerp matching placebo BID for 1 day
This is a randomized, double-blind study.
Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | Drug: Ibrexafungerp300 mg BID for one day |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Key exclusion criteria (5 listed)
- 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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
- 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.
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 |
|---|---|---|
| IbrexafungerpAlso: SCY-078Ibrexafungerp 300mg BID for one day | Drug | Ibrexafungerp (SCY-078) |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
Clinical Cure (Complete Resolution of Signs and Symptoms)
Time frame: Day 8-14
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
4 secondary outcomes
Mycological Eradication (Negative Culture for Growth of Yeast)
Time frame: Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
Time frame: Day 8-14
Complete Clinical Response at Follow-up
Time frame: Day 25
Safety and Tolerability of Ibrexafungerp
Time frame: Up to 29 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36255448Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibrexafungerp in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 41 sites in 2 countries.
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 2 inclusion and 5 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Bulgaria. 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 8 Sep 2021). 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 Cure (Complete Resolution of Signs and Symptoms) (time frame: Day 8-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987620, which also lists 1 linked publication.
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 8 Sep 2021.