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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2019-002600-40
    Trial protocol
    		 PL   BG  
    Global end of trial date
    29 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SCY-078-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04029116
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 107521
    Sponsors
    Sponsor organisation name
    SCYNEXIS, Inc.
    Sponsor organisation address
    1 Evertrust Plaza, Jersey City, United States, NJ 07302
    Public contact
    VANISH Study Team, SCYNEXIS, Inc., +1 201688 2241, info@scynexis.com
    Scientific contact
    VANISH Study Team, SCYNEXIS, Inc., +1 201688 2241, info@scynexis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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) based on clinical success
    Protection of trial subjects
    The study was conducted in accordance with the protocol, the ethical principles established by the Declaration of Helsinki (as amended in Fortaleza, Brazil, October 2013), the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, the United States Code of Federal Regulations (CFR) sections that address clinical research studies, applicable European Union regulations and/or other national and local ethical and legal requirements, as applicable. The ICH issued guidelines to provide protection for human subjects in clinical investigations. The ICH Tripartite Guideline for GCP establishes the general requirements for informed consent. Each subject was provided with oral and written information in a language they could understand that described the nature and duration of the study. Before undergoing screening, each subject consented in writing to study participation. The patient signed and personally dated the subject ICF.
    Background therapy
    		 Oral fluconazole 150 mg once a day (QD) on Days -14, -11, and -8 was administrated during Acute phase before Prevention of recurrence phase.
    Evidence for comparator
    		 Matching oral placebo in Prevention of recurrence phase.
    Actual start date of recruitment
    03 Sep 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Bulgaria: 72
    Country: Number of subjects enrolled
    Russian Federation: 74
    Country: Number of subjects enrolled
    United States: 106
    Worldwide total number of subjects
    284
    EEA total number of subjects
    104
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    283
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled into the study. A total of 260 subjects entered the Prevention of Recurrence Phase (130 subjects each randomly assigned to ibrexafungerp group and placebogroup) and 24 subjects entered the Nested Substudy.

    Pre-assignment
    Screening details
    		 A total of 530 subjects were screened; of these, 90 subjects were screen failures before Acute Phase. Medical history, physical examination, vital sign measurements and safety laboratory tests were performed at the Screening Visit and prior to administration of the initial dose of study drug.

    Period 1
    Period 1 title
    Prevention of Recurrence Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject
    Blinding implementation details
    This was a randomized, double blind study. All site and Sponsor personnel were blinded to treatment assignment. The investigator was unblinded only if it was necessary to determine treatment of emergency.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibrexafungerp
    Arm description
    		 130 subjects were assigned to ibrexafungerp group. Oral ibrexafungerp administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibrexafungerp
    Investigational medicinal product code
    Other name
    SCY-078
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral ibrexafungerp administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments (Baseline [Day 1], Week 4, Week 8, Week 12, Week 16, and Week 20). Each single-day treatment consisted of 2 doses of 300 mg each given 12 (±4) hours apart (total single-day dose = 600 mg).

    Arm title
    		 Placebo
    Arm description
    		 130 subjects were assigned to Placebo group. Oral Placebo administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching oral placebo administered as a single day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single day treatments (Baseline [Day 1], Week 4, Week 8, Week 12, Week 16, and Week 20). Each single day treatment consisted of 2 doses of placebo given 12 (±4) hours apart.

    Number of subjects in period 1 [1]
    		Ibrexafungerp Placebo
    Started
    130
    130
    Completed
    118
    114
    Not completed
    12
    16
         Physician decision
    2
    -
         Consent withdrawn by subject
    4
    6
         Other
    2
    1
         Pregnancy
    1
    2
         Adverse event
    -
    2
         Lost to follow-up
    3
    5
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The study consisted of a main study and a sub-study. The subject enrolled are entered for both main study and sub-study. The baseline period consisted of subjects only from the main study as the primary endpoints were based on the main study. The sub-study has supported the results from the main study, providing exploratory results.
    Period 2
    Period 2 title
    Ibrexafungerp Nested Sub-Study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was open-label period.

    Arms
    Arm title
    		 Ibrexafungerp
    Arm description
    		 Nested Sub-Study was an exploratory, open-label, single group study to evaluate the efficacy and safety of oral ibrexafungerp in the treatment of acute episodes of VVC in subjects with a history of RVVC who had not responded to 3 doses of oral fluconazole treatment in Acute phase. All subjects received oral ibrexafungerp administered as a single day treatment (baseline [Day 1]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibrexafungerp
    Investigational medicinal product code
    Other name
    SCY-078
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All subjects received oral ibrexafungerp 150mg tablets administered orally as a single-day treatment (baseline [Day 1]) consisting of two 300-mg doses (total dose = 600 mg) given 12 hours apart (±4 hours). The study drug was administered preferably with or immediately after a meal.

    Number of subjects in period 2 [2]
    		Ibrexafungerp
    Started
    24
    Completed
    23
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The study consisted of a main study and a sub-study. Subjects with a history of recurrent VVC (enrolled in the main study with an acute VVC episode), who had a culture-confirmed VVC at screening during main study and failed oral fluconazole were eligible for this sub-study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 130 subjects were assigned to ibrexafungerp group. Oral ibrexafungerp administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.

    Reporting group title
    Placebo
    Reporting group description
    		 130 subjects were assigned to Placebo group. Oral Placebo administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.

    Reporting group values
    		 Ibrexafungerp Placebo Total
    Number of subjects
    		 130 130 260
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 129 130 259
        From 65-84 years
    		 1 0 1
    Age continuous
    Units: years
        geometric mean (full range (min-max))
    		 34.1 (18 to 65) 33.7 (18 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 130 130 260
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Intent-to-Treat (ITT) Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo).

    Subject analysis set title
    Modified Intent-to-Treat (mITT) Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo), who had a confirmed mycological culture for yeast at Screening and a negative culture for yeast at Baseline (Day 1).

    Subject analysis set title
    Per Protocol (PP) Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All mITT subjects who did not have major protocol deviations likely to affect study efficacy and who had available data at the TOC visit.

    Subject analysis set title
    Safety Set (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo) and who had at least one postbaseline evaluation.

    Subject analysis sets values
    		 Intent-to-Treat (ITT) Set Modified Intent-to-Treat (mITT) Set Per Protocol (PP) Set Safety Set (SS)
    Number of subjects
    260
    219
    182
    260
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    159
    159
        From 65-84 years
    1
    1
    Age continuous
    Units: years
        geometric mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    260
    219
    182
    260
        Male
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 130 subjects were assigned to ibrexafungerp group. Oral ibrexafungerp administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.

    Reporting group title
    Placebo
    Reporting group description
    		 130 subjects were assigned to Placebo group. Oral Placebo administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 Nested Sub-Study was an exploratory, open-label, single group study to evaluate the efficacy and safety of oral ibrexafungerp in the treatment of acute episodes of VVC in subjects with a history of RVVC who had not responded to 3 doses of oral fluconazole treatment in Acute phase. All subjects received oral ibrexafungerp administered as a single day treatment (baseline [Day 1]).

    Subject analysis set title
    Intent-to-Treat (ITT) Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo).

    Subject analysis set title
    Modified Intent-to-Treat (mITT) Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo), who had a confirmed mycological culture for yeast at Screening and a negative culture for yeast at Baseline (Day 1).

    Subject analysis set title
    Per Protocol (PP) Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All mITT subjects who did not have major protocol deviations likely to affect study efficacy and who had available data at the TOC visit.

    Subject analysis set title
    Safety Set (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug (ibrexafungerp or placebo) and who had at least one postbaseline evaluation.

    Primary: The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Intent-to-Treat Set)

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    End point title
    		 The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Intent-to-Treat Set)
    End point description
    The primary efficacy endpoint was defined as the proportion of ITT subjects who had documented clinical success (defined as subjects having a TOC evaluation and no mycologically proven, presumed, or suspected recurrences of VVC) up to Week 24 (TOC).
    End point type
    Primary
    End point timeframe
    Up to Week 24 (TOC)
    End point values
    		 Ibrexafungerp Placebo
    Number of subjects analysed
    130
    130
    Units: percent
    number (not applicable)
        Clinical Success (%)
    65.4
    53.1
        Clinical Failure (%)
    34.6
    46.9
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    All analyses were conducted using SAS Version 9.4 or higher. A Cochran-Mantel-Haenszel (CMH) test was used. Continuous data were described using descriptive statistics (ie, n, mean, standard deviation [SD], median, minimum, and maximum). Categorical data were described using the subject count and percentage in each category.
    Comparison groups
    Ibrexafungerp v Placebo
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative Risk for Response
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.034
         upper limit
    		 1.486

    Primary: The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Modified Intent-to-Treat Set)

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    End point title
    		 The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Modified Intent-to-Treat Set)
    End point description
    The primary efficacy endpoint was defined as the proportion of mITT subjects who had documented clinical success (defined as subjects having a TOC evaluation and no mycologically proven, presumed, or suspected recurrences of VVC) up to Week 24 (TOC).
    End point type
    Primary
    End point timeframe
    Up to Week 24 (TOC)
    End point values
    		 Ibrexafungerp Placebo
    Number of subjects analysed
    112
    107
    Units: percent
    number (not applicable)
        Clinical Success (%)
    67.0
    57.0
        Clinical Failure (%)
    33.0
    43.0
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    All analyses were conducted using SAS Version 9.4 or higher. A Cochran-Mantel-Haenszel (CMH) test was used. Continuous data were described using descriptive statistics (ie, n, mean, standard deviation [SD], median, minimum, and maximum). Categorical data were described using the subject count and percentage in each category.
    Comparison groups
    Ibrexafungerp v Placebo
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative Risk for Response
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.017
         upper limit
    		 1.465

    Primary: The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Per-Protocol Set)

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    End point title
    		 The Proportion of Subjects Who Have Documented Clinical Success up to Week 24 (TOC)–Main Study (Per-Protocol Set)
    End point description
    The primary efficacy endpoint was defined as the proportion of PP subjects who had documented clinical success (defined as subjects having a TOC evaluation and no mycologically proven, presumed, or suspected recurrences of VVC) up to Week 24 (TOC).
    End point type
    Primary
    End point timeframe
    Up to Week 24 (TOC)
    End point values
    		 Ibrexafungerp Placebo
    Number of subjects analysed
    94
    88
    Units: percent
    number (not applicable)
        Clinical Success (%)
    76.96
    65.9
        Clinical Failure (%)
    23.4
    34.1
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    All analyses were conducted using SAS Version 9.4 or higher. A Cochran-Mantel-Haenszel (CMH) test was used. Continuous data were described using descriptive statistics (ie, n, mean, standard deviation [SD], median, minimum, and maximum). Categorical data were described using the subject count and percentage in each category.
    Comparison groups
    Ibrexafungerp v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative Risk for Response
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.026
         upper limit
    		 1.448

    Secondary: The Proportion of Subjects Who Have no Mycologically Proven Recurrence at Week 24 (TOC)–Main Study (Intent-to-Treat Set)

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    End point title
    		 The Proportion of Subjects Who Have no Mycologically Proven Recurrence at Week 24 (TOC)–Main Study (Intent-to-Treat Set)
    End point description
    The secondary efficacy endpoint was 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) up to Week 24 (TOC).
    End point type
    Secondary
    End point timeframe
    Up to week 24 (TOC)
    End point values
    		 Ibrexafungerp Placebo
    Number of subjects analysed
    130
    130
    Units: percent
    number (not applicable)
        No Mycologically Proven Recurrence (%)
    70.8
    58.5
        Mycologically Proven Recurrences (%)
    29.2
    41.5
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    All analyses were conducted using SAS Version 9.4 or higher. A Cochran-Mantel-Haenszel (CMH) test was used. Continuous data were described using descriptive statistics (ie, n, mean, standard deviation [SD], median, minimum, and maximum). Categorical data were described using the subject count and percentage in each category.
    Comparison groups
    Ibrexafungerp v Placebo
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative Risk for Response
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.032
         upper limit
    		 1.43

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The TEAEs were presented from baseline to TOC (ie, 4 weeks after last dose) and from TOC to EOFU in addition to the entire study period. The safety results are presented for the entire study period.
    Adverse event reporting additional description
    Ibrexafungerp was generally well-tolerated by subjects with RVVC when administered as a 300-mg oral tablet BID every 4 weeks for total of 24 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Ibrexafungerp
    Reporting group description
    		 130 subjects were assigned to ibrexafungerp group. Oral ibrexafungerp administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.

    Reporting group title
    Placebo
    Reporting group description
    		 130 subjects were assigned to Placebo group. Oral Placebo administered as a single-day treatment repeated every 4 weeks (28 days [±3]) for a total of 6 single-day treatments.

    Serious adverse events
    		 Ibrexafungerp Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 130 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Ibrexafungerp Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 130 (64.62%)
    74 / 130 (56.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 130 (19.23%)
    11 / 130 (8.46%)
         occurrences all number
    25
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 130 (3.08%)
    0 / 130 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 130 (7.69%)
    5 / 130 (3.85%)
         occurrences all number
    10
    5
    Nausea
         subjects affected / exposed
    7 / 130 (5.38%)
    5 / 130 (3.85%)
         occurrences all number
    7
    5
    Abdominal pain upper
         subjects affected / exposed
    7 / 130 (5.38%)
    4 / 130 (3.08%)
         occurrences all number
    7
    4
    Abdominal pain
         subjects affected / exposed
    5 / 130 (3.85%)
    4 / 130 (3.08%)
         occurrences all number
    5
    4
    Abdominal discomfort
         subjects affected / exposed
    2 / 130 (1.54%)
    3 / 130 (2.31%)
         occurrences all number
    2
    3
    Toothache
         subjects affected / exposed
    2 / 130 (1.54%)
    3 / 130 (2.31%)
         occurrences all number
    2
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 130 (2.31%)
    3 / 130 (2.31%)
         occurrences all number
    3
    3
    Vaginal discharge
         subjects affected / exposed
    3 / 130 (2.31%)
    0 / 130 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 130 (3.85%)
    4 / 130 (3.08%)
         occurrences all number
    5
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 130 (1.54%)
    3 / 130 (2.31%)
         occurrences all number
    2
    3
    Back pain
         subjects affected / exposed
    3 / 130 (2.31%)
    1 / 130 (0.77%)
         occurrences all number
    3
    1
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    10 / 130 (7.69%)
    11 / 130 (8.46%)
         occurrences all number
    10
    11
    COVID-19
         subjects affected / exposed
    7 / 130 (5.38%)
    5 / 130 (3.85%)
         occurrences all number
    7
    5
    Urinary tract infection
         subjects affected / exposed
    5 / 130 (3.85%)
    2 / 130 (1.54%)
         occurrences all number
    5
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 130 (2.31%)
    3 / 130 (2.31%)
         occurrences all number
    3
    3
    Respiratory tract infection
         subjects affected / exposed
    2 / 130 (1.54%)
    3 / 130 (2.31%)
         occurrences all number
    2
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 130 (3.08%)
    1 / 130 (0.77%)
         occurrences all number
    4
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 130 (1.54%)
    3 / 130 (2.31%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jul 2020
    Global Protocol Addendum 1 (Global, dated 10 Jul 2020) and country specific Protocol Addendum 3 (Russia and Poland, dated 20 Aug 2020) specified the following changes: • SCY-078-304s inclusion criterion 1 was modified to allow all subjects (regardless of Screening mycology results) who did not respond to fluconazole treatment during the Acute Phase to enter the Nested Substudy.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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