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    Summary
    EudraCT Number:2019-002600-40
    Sponsor's Protocol Code Number:SCY-078-304
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002600-40
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects with Recurrent Vulvovaginal Candidiasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to Check if Ibrexafungerp is Safe and Efficient in Patients with Vaginal Recurrent Thrush.
    A.4.1Sponsor's protocol code numberSCY-078-304
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04029116
    A.5.4Other Identifiers
    Name:INDNumber:107521
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSCYNEXIS, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSCYNEXIS, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCYNEXIS, Inc.
    B.5.2Functional name of contact pointVANISH Study Team
    B.5.3 Address:
    B.5.3.1Street Address1 Evertrust Plaza, 13th Floor
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post codeNJ 07302
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1201688 2241
    B.5.5Fax number+1201884 5490
    B.5.6E-mailinfo@scynexis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIbrexafungerp
    D.3.2Product code SCY - 078
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBREXAFUNGERP
    D.3.9.2Current sponsor codeSCY-078
    D.3.9.4EV Substance CodeSUB193372
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Vulvovaginal Candidiasis
    E.1.1.1Medical condition in easily understood language
    Recurrent Vaginal Thrush
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10047784
    E.1.2Term Vulvovaginal candidiasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of oral ibrexafungerp versus placebo in preventing recurrences of Vulvovaginal Candidiasis (VVC) in subjects with recurrent VVC (RVVC) baseb on clinical success
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of oral ibrexafungerp versus placebo in preventing recurrences of VVC in subjects with RVVC based on Mycologically Proven Recurrences at test of cure (TOC)

    • To evaluate the efficacy of oral ibrexafungerp versus placebo in preventing recurrences (Mycologically Proven, Presumed or Suspected) of VVC in subjects with RVVC.
    • To evaluate the efficacy of oral ibrexafungerp versus placebo in preventing recurrences of VVC in subjects with RVVC based on the number of Recurrences (Mycologically Proven, Presumed or Suspected) of VVC.
    • To evaluate the efficacy of oral ibrexafungerp versus placebo in subjects with RVVC based on Quality-of-Life (QOL) outcomes.
    • To evaluate the safety and tolerability of oral ibrexafungerp in subjects with RVVC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An exploratory, open-label, single-group ibrexafungerp sub-study to evaluate the efficacy and safety of oral ibrexafungerp in the treatment of acute VVC in patients with recurrent VVC that has not responded to oral fluconazole treatment
    E.3Principal inclusion criteria
    1. Subject is a postmenarchal female subject 18 years and older and is in good general health based on medical history, physical examination, vital sign measurements and safety laboratory tests performed at the Screening visit and prior to administration of the initial dose of study drug.
    2. Subject has a diagnosis of symptomatic VVC that meets the following criteria at Screening:
    a. A total composite score of ≥ 4 on the VSS Scale
    b. Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
    c. Normal vaginal pH (≤ 4.5)
    d. A minimum of three episodes of VVC in the past 12 months, including the current episode, that required administration of antifungal medication. Besides the current episode, at least one of the previous episodes in the past 12 months is required to have been a physician-diagnosed episode of VVC, with at least one positive test confirming vaginal yeast infection (e.g., KOH, culture or fungal polymerase chain reaction)
    3. Subject meets the following criteria at Baseline (Day 1):
    a. Significant resolution of signs and symptoms of Candida infection (total composite score ≤ 2 on the VSS Scale)
    b. Culture positive for Candida spp. in a vaginal sample collected at Screening
    c. Normal vaginal pH (≤ 4.5)
    4. Subject is able to take oral tablets and capsules.
    5. Subject is not pregnant or lactating and is highly unlikely to become pregnant since she meets at least one of the following criteria:
    a. Subject is a female subject who is not of reproductive potential and is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who: (1) has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) has undergone bilateral oophorectomy and/or hysterectomy or (3) is 3 months post bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa).
    b. Subject is a female subject who is of reproductive potential and is using an effective contraceptive method including intrauterine device, systemic hormonal contraceptives (i.e., implant, oral, injectable or patch) for at least 30 days before Baseline and agrees to continue using the contraceptive method through at least 10 days after the completion of study therapy. Subjects who are taking hormonal contraceptives must use a non-hormonal barrier method of contraception until 10 days after the last dose of study drug. Vasectomy in the male partner is also an acceptable contraceptive method as long as performed at least 3 months prior to Baseline.
    c. Subject is a female subject who is of reproductive potential and agrees to remain abstinent or use (or have her partner use) an acceptable barrier contraceptive method from the time of consent through 10 days after the completion of study therapy. Acceptable barrier methods of contraception for this study are: male condom, female condom and diaphragm.
    Note: Subjects must refrain from using any topical vaginal contraceptives such as spermicides or intra-vaginal hormonal contraceptive devices such as vaginal rings as these may interfere with the efficacy evaluations.
    Note: Women of childbearing potential must have a negative urine pregnancy test (sensitivity ≥25 mIU/human chorionic gonadotropin [hCG]) prior to enrollment at Screening and at Baseline (performed by the site’s local laboratory).
    6. Subject and/or parent/legal representative is able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures. For subjects under the legal age of consent, the subject’s parent or legal representative must also be willing and able to sign the subject’s ICF.
    7. Subject and/or parent/legal representative 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 United States Health Information Portability and Accountability Act Authorization form).
    8. Subject and/or parent/legal representative is able to understand and follow all study-related procedures including study drug administration.
    E.4Principal exclusion criteria
    1. Subject has any vaginal condition other than RVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed 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 28 days prior to the Day -14 visit.
    3. Subject is receiving or anticipates to require treatment with the prohibited medications (including prescription and over-the-counter medications, supplements, and herbal products) listed in Section 21.0 (Appendix A of the protocol), during the following timeframes:
    a. Systemic and topical vaginal antifungal treatment other than study drug and rescue medication (if needed), as specified in the protocol, anytime during the study.
    b. Select CYP3A4/5 inducers during the 14 days prior to enrollment and during study treatment.
    c. Select strong CYP3A4/5 inhibitors during 48 hours prior to enrollment and during study treatment.
    d. Select P-gp substrates during the 48 hours prior to enrollment or during study treatment with ibrexafungerp.
    e. Topical vaginal corticosteroids from 7 days prior to the Screening visit to the Week 24 (TOC) visit.
    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 fluconazole or any of the components of the fluconazole or ibrexafungerp formulations.
    7. Subject has a known human immunodeficiency virus infection and/or is receiving chemotherapy, has recently received immunosuppressive or systemic corticosteroid therapies, or has an illness that, in the judgment of the investigator, is serious enough to induce an immune deficiency.
    8. Subject has had any major illness within 30 days before Screening.
    9. Subject has participated in any other investigational study within at least 30 days (or 5.5 half-lives of the investigational product, whichever is longer) before signing the ICF.
    10. Subject has received prior treatment with the study drug in a previous trial.
    11. Subject has any other condition or laboratory abnormality evidencing a major organ system disease 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.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy as measured by the percentage of subjects with documented Clinical Success (defined as subjects having a TOC evaluation and no Mycologically Proven, Presumed or Suspected Recurrence of VVC) up to TOC (Week 24).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Test-of-cure (TOC) visit
    E.5.2Secondary end point(s)
    • Efficacy as measured by the percentage of subjects with no Mycologically Proven Recurrence (defined as an episode of VVC with a total composite score ≥ 3 on the VSS Scale and a culture positive for Candida spp. that required antifungal treatment) at TOC (Week 24).

    Efficacy as measured by:
    • The percentage of subjects with no Mycologically Proven Recurrence at Week 4, Week 8, Week 12 and Week 36 (end of follow-up [EOFU]).
    • The time to the first Recurrence (Mycologically Proven, Presumed or Suspected) of VVC through EOFU.
    • The percentage of subjects with Mycological Eradication (negative fungal culture) at Week 12, Week 24 (TOC) and Week 36 (EOFU).
    • The percentage of subjects with no Mycologically Proven, Presumed or Suspected Recurrences at Week 4, Week 8, Week 12 and Week 36 (EOFU).
    • The percentage of subjects with no Mycologically Proven or Presumed Recurrences at Week 4, Week 8, Week 12, TOC (Week 24) and Week 36 (EOFU).
    • The proportion of subjects in three ordered categories related to the number of Recurrences (Mycologically Proven, Presumed or Suspected) of VVC from Baseline (Day 1) to TOC (Week 24) and Week 36 (EOFU). The three categories of recurrence are defined as (i) 0 to 1 episodes, (ii) 2 to 3 episodes, and (iii) ≥ 4 episodes.
    • The absolute number of Mycologically Proven, Presumed or Suspected Recurrences from Baseline (Day 1) to TOC (Week 24) and Week 36 (EOFU).
    • Absolute improvement in QOL outcomes at Week 12, Week 24 (TOC) and Week 36 (EOFU) as measured by EQ-5D, SF-36 and FSDS).
    Safety and tolerability as measured by:
    • AEs, vital signs, treatment discontinuation and safety laboratory tests at TOC (Week 24).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Test-of-cure (TOC) visit and Follow-up (FU) visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Poland
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 320
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-29
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