A Phase 3 interventional study of Ibrexafungerp and Placebo in Candida Vulvovaginitis, sponsored by Scynexis, Inc.. Completed at 25 sites in United States. Open to female participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Scynexis, Inc. · Phase 3, Interventional, and Treatment
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.
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:
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 376 is above the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Drug: Ibrexafungerp
Matching Placebo
Drug: Placebo
Ibrexafungerp 300 mg BID for 1 day
Also known as: SCY-078
Matching placebo
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
Time frame: Day 8-14
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
Time frame: Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Time frame: Day 8-14
Complete Clinical Response at Follow-Up
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Time frame: Day 25
Overall Treatment-Emergent Adverse Events (Safety Set)
Number of subjects with treatment related adverse events
Time frame: Up to 29 days
Participants were recruited based on physician referral at 28 medical centers between 04Jan2019 and 04Sep2019.
| Milestone | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Started | 249 | 127 |
| Withdrawn before treatment | 2 | 3 |
| Withdrawn before toc | 59 | 41 |
| Completed the toc visit | 188 | 83 |
| Withdrawn at or after the toc visit | 5 | 3 |
| Completed | 183 | 80 |
| Not completed | 66 | 47 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Withdrawal by subject | 6 | 3 |
| Withdrew: Lack of efficacy and or/use of antifungal therapy | 49 | 41 |
| Withdrew: Other | 2 | 2 |
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
| Participants | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Clinical cure | 95 | 28 |
| Clinical failure | 93 | 70 |
percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
| Participants | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Mycological eradication | 93 | 19 |
| Mycological persistence | 95 | 79 |
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
| Participants | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Overall success | 64 | 12 |
| Overall failure | 114 | 83 |
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
| Participants | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Clinical cure at Follow up | 113 | 44 |
| Clinical failure at Follow up | 77 | 56 |
Number of subjects with treatment related adverse events
| Participants | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Any treatment-emergent, treatment-related adverse event | 98 | 21 |
| No treatment-emergent, treatment-related adverse events | 149 | 103 |
Collected over 4 weeks after last dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | 0/247 (0%) | 1/247 (0.4%) | 117/247 (47.4%) |
| Placebo | 0/124 (0%) | 2/124 (1.6%) | 34/124 (27.4%) |
| Event | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| HypokalaemiaInvestigations | 0/247 | 1/124 |
| Diabetes mellitusMetabolism and nutrition disorders | 0/247 | 1/124 |
| Pneumonia and bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 1/247 | 0/124 |
| Event | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 63/247 | 8/124 |
| NauseaGastrointestinal disorders | 40/247 | 7/124 |
| HeadacheNervous system disorders | 23/247 | 11/124 |
| Bacterial vaginosisInfections and infestations | 13/247 | 10/124 |
| Abdominal painGastrointestinal disorders | 17/247 | 3/124 |
| Abdominal discomfortGastrointestinal disorders | 14/247 | 2/124 |
| Age, Categorical(Participants) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 244 | 120 | 364 |
| >=65 years | 3 | 3 | 6 |
| Age, Continuous(years) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| Mean | 34.5 ± 11.22 | 35.8 ± 12.47 | 34.9 ± 11.63 |
| Sex: Female, Male(Participants) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| Female | 247 | 124 | 371 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 64 | 25 | 89 |
| Not Hispanic or Latino | 183 | 99 | 282 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 101 | 51 | 152 |
| White | 132 | 71 | 203 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 2 | 10 |
| Region of Enrollment(participants) | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|
| United States | 247 | 124 | 371 |
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Scynexis, Inc.