search
Back to results

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

Primary Purpose

Vulvovaginal Candidiasis

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibrexafungerp
Sponsored by
Scynexis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring vulvovaginal candidiasis, candida, VVC, rVVC, Ibrexafungerp, yeast vaginitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Precision Trials, AZ
  • Women's Healthcare Research
  • Wake Research (MCCR)
  • New Age Medical Research
  • Wake (Mount Vernon Clinical Research)
  • Clinical Research Prime
  • Leavitt Women's Healthcare
  • Women Under Study
  • Massachusetts's General
  • Wayne State University
  • Consultants in Women's Healthcare
  • Wake Research (CRCN)
  • Capital Health Lawrence OBGYN
  • Center for Colposcopy
  • Wake Research (Carolina Institute for Clinical Research)
  • UWCR - Raleigh
  • Lyndhurst Clinical Research
  • Cleveland Clinic
  • Oregon Health and Science University
  • Jefferson University
  • Medical Research Center
  • Discovery Clinical Trials
  • TMC Life Research, Inc
  • Discovery Clinical Trials
  • Seattle Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B (3 Day dosing)

Group b (7 Day dosing)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Clinical Cure
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
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
Percentage of subjects with a 50% reduction from Baseline in total composite VSS score.

Full Information

First Posted
May 23, 2022
Last Updated
June 20, 2023
Sponsor
Scynexis, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05399641
Brief Title
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
Official Title
Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
vulvovaginal candidiasis, candida, VVC, rVVC, Ibrexafungerp, yeast vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, 3 group, stratified
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Arm Title
Group B (3 Day dosing)
Arm Type
Experimental
Arm Description
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Arm Title
Group b (7 Day dosing)
Arm Type
Experimental
Arm Description
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Intervention Type
Drug
Intervention Name(s)
Ibrexafungerp
Intervention Description
Each day dosing will consist of two 150mg tablets taken BID.
Primary Outcome Measure Information:
Title
Clinical Cure
Description
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.
Time Frame
14 Days post Baseline
Secondary Outcome Measure Information:
Title
Clinical Improvement
Description
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.
Time Frame
14 Days post Baseline through 60 days post End of Treatment
Title
Clinical Success
Description
Percentage of subjects with a 50% reduction from Baseline in total composite VSS score.
Time Frame
14 Days post Baseline through 60 days post End of Treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nkechi Azie, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Precision Trials, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Women's Healthcare Research
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Wake Research (MCCR)
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
New Age Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Wake (Mount Vernon Clinical Research)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Leavitt Women's Healthcare
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Women Under Study
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Facility Name
Massachusetts's General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Consultants in Women's Healthcare
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Wake Research (CRCN)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Capital Health Lawrence OBGYN
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Center for Colposcopy
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Wake Research (Carolina Institute for Clinical Research)
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
UWCR - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Discovery Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
TMC Life Research, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Discovery Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

We'll reach out to this number within 24 hrs