Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

NCT05399641 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SCY-078-307b
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 25

Brief Summary

This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.

Conditions

Vulvovaginal Candidiasis

Keywords

vulvovaginal candidiasis; candida; VVC; rVVC; Ibrexafungerp; yeast vaginitis

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.

  14 days post-Baseline - Test-Of-Cure (TOC)

Secondary Outcomes (7)

• Clinical Improvement

  14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment

• Clinical Success

  14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.

• Mycological Response

  14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.

• Clinical Cure and Mycological Response

  14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment

• Clinical Cure at Follow-up

  14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT

Study Arms (3)

Group A

EXPERIMENTAL

Subjects without underlying medical conditions and have isolates other than C glabrata, C krusei, C auris. Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.

Drug: Ibrexafungerp

Group B (3 Day dosing)

EXPERIMENTAL

Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.

Drug: Ibrexafungerp

Group B (7 Day dosing)

EXPERIMENTAL

Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day

Drug: Ibrexafungerp

Interventions

Ibrexafungerp DRUG

Each day dosing will consist of two 150mg tablets taken BID.

Group A; Group B (3 Day dosing); Group B (7 Day dosing)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a post menarchal female ≥18 years of age at the time of signing the ICF.
• Subject has a diagnosis of symptomatic VVC that meets the following criteria at the
• Screening visit:
• Minimum composite vulvovaginal signs and symptoms score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater on the VSS scale at baseline.
• Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
• Normal vaginal pH (≤ 4.5).
• Has no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).
• Subject should also have:
• A VVC with persistent symptoms despite fluconazole therapy (last dose of fluconazole must have been administered at least 7 days prior, but no longer than 28 days prior to screening. OR
• A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR
• A VVC episode caused by a non-albicans candida species known to have either intrinsic resistance to fluconazole e.g. C.krusei or suspected resistance to fluconazole, e.g. C.glabrata, C. auris but likely without MIC data in hand. OR
• A VVC episode caused by Candida species with documented resistance to fluconazole based on MIC determination. OR
• A known history of azole allergy or intolerance.
• Subject is able to take oral tablets.
• Subject is not pregnant or lactating and plans not to become pregnant. Women of childbearing potential \< 1 year post-menopausal must agree to and comply with using one barrier method (male condom, female condom, and diaphragm) plus one other highly effective method of birth control, or sexual abstinence, from the time of consent through 10 days after the completion of study therapy. Subjects must refrain from using any topical vaginal contraceptives as these may have an impact on the signs and symptoms of VVC. Note: Women of childbearing potential must have a negative urine pregnancy test prior to enrollment (performed by the site's local laboratory).

You may not qualify if:

• Subject has any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy, such as concurrent causes of vulvovaginitis and/or cervicitis including bacterial vaginosis, Trichomonas, Herpes virus, Neisseria gonorrhoeae, Chlamydia, symptomatic human papillomavirus infection, or other mixed infections.
• Subject received systemic and/or topical vaginal antifungal treatment, including prescription or over-the-counter products, within 7 days prior to the Screening visit.
• Note: The screening visit may be rescheduled if required.
• Subject is receiving or anticipates requiring treatment with the prohibited medications within the specified timeframes per Appendix I.
• Subject has active menstruation at the Screening visit. Note: The Screening visit may be rescheduled if required.
• Subject has a history of or an active cervical/vaginal cancer.
• Subject has a known hypersensitivity to any of the components of the formulation.
• Subject has participated in any other investigational study within at least 30 days (or 5.5 half- lives of the investigational product) before signing the ICF.
• Subject has received prior treatment with ibrexafungerp.
• Subject has any other condition or laboratory abnormality (such as severe hepatic impairment) that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
• Subject is unlikely to comply with protocol requirements.

Sponsors & Collaborators

• Scynexis, Inc.: lead

Study Sites (25)

Precision Trials, AZ

Phoenix, Arizona, 85032, United States

Location

Women's Healthcare Research

San Diego, California, 92111, United States

Location

Wake Research (MCCR)

San Diego, California, 92120, United States

Location

New Age Medical Research

Miami, Florida, 33186, United States

Location

Wake (Mount Vernon Clinical Research)

Atlanta, Georgia, 30328, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Leavitt Women's Healthcare

Idaho Falls, Idaho, 83404, United States

Location

Women Under Study

New Orleans, Louisiana, 70125, United States

Location

Massachusetts's General

Boston, Massachusetts, 02114, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Consultants in Women's Healthcare

St Louis, Missouri, 63131, United States

Location

Wake Research (CRCN)

Las Vegas, Nevada, 89123, United States

Location

Capital Health Lawrence OBGYN

Lawrenceville, New Jersey, 08648, United States

Location

Center for Colposcopy

Lake Success, New York, 11042, United States

Location

Wake Research (Carolina Institute for Clinical Research)

Fayetteville, North Carolina, 28303, United States

Location

UWCR - Raleigh

Raleigh, North Carolina, 27607, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical Research Center

Memphis, Tennessee, 38120, United States

Location

Discovery Clinical Trials

Dallas, Texas, 75230, United States

Location

TMC Life Research, Inc

Houston, Texas, 77054, United States

Location

Discovery Clinical Trials

McAllen, Texas, 78503, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Torulopsis

Interventions

ibrexafungerp

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: David Angulo
• Organization: Scynexis

david.angulo@scynexis.com

201-884-5471

Study Officials

• Lori Tierney

  Scynexis, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, 3 group, stratified

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: May 1, 2022
• Primary Completion: May 16, 2023
• Study Completion: August 2, 2023
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Locations

US (25)