Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

NCT ID: NCT05399641

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-08-02

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.

Detailed Description

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

Approximately 150 eligible subjects will be enrolled. Subjects will be randomized to receive oral ibrexafungerp 300 mg administered twice a day (BID) for either one, three, or seven consecutive days, stratified by group based on Candida species and presence or absence of underlying medical conditions.

The primary endpoint for this study is the percentage of subjects with a clinical cure at the Test of Cure Visit. Test of Cure is defined as a score of zero on the Vulvovaginal Signs and Symptoms Scale and not requiring additional antifungal treatment.

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Ibrexafungerp

Intervention Type: DRUG

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

Group B (3 Day dosing)

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.

Group Type: EXPERIMENTAL

Ibrexafungerp

Intervention Type: DRUG

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

Group B (7 Day dosing)

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

Group Type: EXPERIMENTAL

Ibrexafungerp

Intervention Type: DRUG

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

Interventions

Ibrexafungerp

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject is a post menarchal female ≥18 years of age at the time of signing the ICF.

2. Subject has a diagnosis of symptomatic VVC that meets the following criteria at the

Screening visit:

1. 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.

2. Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts

3. Normal vaginal pH (≤ 4.5).

4. Has no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).

3. Subject should also have:

1. 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

2. A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR

3. 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

4. A VVC episode caused by Candida species with documented resistance to fluconazole based on MIC determination. OR

5. A known history of azole allergy or intolerance.

4. Subject is able to take oral tablets.

5. 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).

6. Subject is able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.

7. Subject is able 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 US Health Information Portability and Accountability Act Authorization form).

8. Subject is able to understand and follow all study-related procedures including study drug administration.

Exclusion Criteria

1. 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.

2. 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.

3. Subject is receiving or anticipates requiring treatment with the prohibited medications within the specified timeframes per Appendix I.

4. Subject has active menstruation at the Screening visit. Note: The Screening visit may be rescheduled if required.

5. Subject has a history of or an active cervical/vaginal cancer.

6. Subject has a known hypersensitivity to any of the components of the formulation.

7. 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.

8. Subject has received prior treatment with ibrexafungerp.

9. 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.

10. Subject is unlikely to comply with protocol requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Tierney

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

Precision Trials, AZ

Phoenix, Arizona, United States

Women's Healthcare Research

San Diego, California, United States

Wake Research (MCCR)

San Diego, California, United States

New Age Medical Research

Miami, Florida, United States

Wake (Mount Vernon Clinical Research)

Atlanta, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Leavitt Women's Healthcare

Idaho Falls, Idaho, United States

Women Under Study

New Orleans, Louisiana, United States

Massachusetts's General

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Consultants in Women's Healthcare

St Louis, Missouri, United States

Wake Research (CRCN)

Las Vegas, Nevada, United States

Capital Health Lawrence OBGYN

Lawrenceville, New Jersey, United States

Center for Colposcopy

Lake Success, New York, United States

Wake Research (Carolina Institute for Clinical Research)

Fayetteville, North Carolina, United States

UWCR - Raleigh

Raleigh, North Carolina, United States

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Jefferson University

Philadelphia, Pennsylvania, United States

Medical Research Center

Memphis, Tennessee, United States

Discovery Clinical Trials

Dallas, Texas, United States

TMC Life Research, Inc

Houston, Texas, United States

Discovery Clinical Trials

McAllen, Texas, United States

Seattle Clinical Research Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SCY-078-307b

Identifier Type: -

Identifier Source: org_study_id