Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

Sponsor

Scynexis, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05399641

Collaborator

(none)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiasis	Drug: Ibrexafungerp	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open-label, 3 group, stratifiedOpen-label, 3 group, stratified

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.	Drug: Ibrexafungerp Each day dosing will consist of two 150mg tablets taken BID.
Experimental: Group B (3 Day dosing) Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.	Drug: Ibrexafungerp Each day dosing will consist of two 150mg tablets taken BID.
Experimental: Group b (7 Day dosing) Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day	Drug: Ibrexafungerp Each day dosing will consist of two 150mg tablets taken BID.

Arm

Intervention/Treatment

Experimental: Group A

Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.

Drug: Ibrexafungerp

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

Experimental: Group B (3 Day dosing)

Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.

Drug: Ibrexafungerp

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

Experimental: Group b (7 Day dosing)

Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day

Drug: Ibrexafungerp

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

Outcome Measures

Primary Outcome Measures

Clinical Cure [14 Days post Baseline]
Measured by the percentage of subjects with clinical cure (total composite score of 0 on the Vulvovaginal Signs and Symptoms [VSS] Scale with no additional antifungal therapy required based on investigator's judgment) at the Test-of-Cure (TOC) visit. The VSS Scale measures 3 signs and 3 symptoms of VVC, each on a scale of 0 (none) to 3 (severe). The minimum score for the VSS is 0 and the maximum is 18, with higher scores indicating more severe disease.

Secondary Outcome Measures

Clinical Improvement [14 Days post Baseline through 60 days post End of Treatment]
Percentage of subjects with a total composite score of 2 and percentage of subjects with a total composite score of 1 on the VSS scale.
Clinical Success [14 Days post Baseline through 60 days post End of Treatment]
Percentage of subjects with a 50% reduction from Baseline in total composite VSS score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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).
Subject is able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.
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).
Subject is able to understand and follow all study-related procedures including study drug administration.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Precision Trials, AZ	Phoenix	Arizona	United States	85032
2	Women's Healthcare Research	San Diego	California	United States	92111
3	Wake Research (MCCR)	San Diego	California	United States	92120
4	New Age Medical Research	Miami	Florida	United States	33186
5	Wake (Mount Vernon Clinical Research)	Atlanta	Georgia	United States	30328
6	Clinical Research Prime	Idaho Falls	Idaho	United States	83404
7	Leavitt Women's Healthcare	Idaho Falls	Idaho	United States	83404
8	Women Under Study	New Orleans	Louisiana	United States	70125
9	Consultants in Women's Healthcare	Saint Louis	Missouri	United States	63131
10	Wake Research (CRCN)	Las Vegas	Nevada	United States	89123
11	Capital Health Lawrence OBGYN	Lawrenceville	New Jersey	United States	08648
12	Wake Research (Carolina Institute for Clinical Research)	Fayetteville	North Carolina	United States	28303
13	UWCR - Raleigh	Raleigh	North Carolina	United States	27607
14	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
15	Unified Women's Clinical Research	Winston-Salem	North Carolina	United States	27103
16	Medical Research Center	Memphis	Tennessee	United States	38120
17	TMC Life Research, Inc	Houston	Texas	United States	77054
18	Seattle Clinical Research Center	Seattle	Washington	United States	98105