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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of LEVI-04 in Patients with Osteoarthritis of the Knee

    Summary
    EudraCT number
    		 2021-006540-28
    Trial protocol
    		 CZ   DK  
    Global end of trial date
    20 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Sep 2025
    First version publication date
    12 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LEVI-04-21-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05618782
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Levicept Ltd
    Sponsor organisation address
    Innovation House, Discovery Park, Ramsgate Road, Sandwich, United Kingdom, CT13 9ND
    Public contact
    Debbie Dutton , Levicept Ltd , 44 07430695385, info@levicept.com
    Scientific contact
    Claire Herholdt, Levicept Ltd , 44 07875737516, claire@levicept.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
    19 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of LEVI-04 (multiple doses) compared to placebo in reducing pain due to knee OA.
    Protection of trial subjects
    Rescue medication (paracetamol, up to 4000mg/day) was provided, to be used if necessary.
    Background therapy
    		 Rescue medication (paracetamol, up to 4000mg/day) was provided, to be used if necessary.
    Evidence for comparator
    		 Saline vehicle was used as placebo and was indistinguishable from active once prepared for administration.
    Actual start date of recruitment
    19 Oct 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 81
    Country: Number of subjects enrolled
    Czechia: 143
    Country: Number of subjects enrolled
    Denmark: 211
    Country: Number of subjects enrolled
    Hong Kong: 66
    Country: Number of subjects enrolled
    Moldova, Republic of: 17
    Worldwide total number of subjects
    518
    EEA total number of subjects
    435
    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)
    236
    From 65 to 84 years
    282
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 19 October 2022 and 23 October 2023 518 participants were enrolled across 13 clinical research centers located in Denmark, Hong Kong, Poland, Moldova and Czech Republic.

    Pre-assignment
    Screening details
    		 1598 participants were screened to enroll 518. Screening period included a diary run-in period; participants had to record a minimum of 4/10 daily pain score. Participants also had to record a minimum of 20/50 points on the WOMAC pain subscore at screening and randomization visits, with at least 48 hours washout of other analgesics.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Randomization performed using a central IVR. There was an unblinded pharmacist at each site to make up the infusions, and an unblinded monitor to perform drug accountability. Once made up, active infusions were indistinguishable from placebo. These roles had to be independent of any other trial activities. All other personnel were blinded to treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEVI-04 0.3mg/kg
    Arm description
    		 LEVI-04 0.3 mg/kg intravenous infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEVI-04
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    LEVI-04 solution diluted with 5% dextrose to make up 0.3mg/kg infusion via saline drip over 30 minutes, once monthly.

    Arm title
    		 LEVI-04 1.0mg/kg
    Arm description
    		 LEVI-04 1.0 mg/kg intravenous infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEVI-04
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    LEVI-04 solution diluted with 5% dextrose to make up 1.0 mg/kg infusion via saline drip over 30 minutes, once monthly.

    Arm title
    		 LEVI-04 2.0 mg/kg
    Arm description
    		 LEVI-04 2.0 mg/kg intravenous infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEVI-04
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    LEVI-04 solution diluted with 5% dextrose to make up 2.0 mg/kg infusion via saline drip over 30 minutes, once monthly.

    Arm title
    		 Placebo
    Arm description
    		 Placebo comparator (saline vehicle)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Intravenous infusion of a saline drip over 30 minutes, once monthly

    Number of subjects in period 1
    		LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Started
    130
    130
    129
    129
    Completed
    120
    121
    118
    116
    Not completed
    10
    9
    11
    13
         Consent withdrawn by subject
    5
    4
    5
    7
         Physician decision
    1
    1
    1
    -
         not known
    -
    1
    -
    -
         Adverse event, non-fatal
    3
    2
    4
    4
         Lost to follow-up
    1
    1
    1
    -
         Protocol deviation
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEVI-04 0.3mg/kg
    Reporting group description
    		 LEVI-04 0.3 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 1.0mg/kg
    Reporting group description
    		 LEVI-04 1.0 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 2.0 mg/kg
    Reporting group description
    		 LEVI-04 2.0 mg/kg intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator (saline vehicle)

    Reporting group values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo Total
    Number of subjects
    		 130 130 129 129 518
    Age categorical
    between ≥40 and ≤80 years of age
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 68 55 67 46 236
        From 65-84 years
    		 62 75 62 83 282
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 67 80 69 76 292
        Male
    		 63 50 60 53 226

    End points

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    End points reporting groups
    Reporting group title
    LEVI-04 0.3mg/kg
    Reporting group description
    		 LEVI-04 0.3 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 1.0mg/kg
    Reporting group description
    		 LEVI-04 1.0 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 2.0 mg/kg
    Reporting group description
    		 LEVI-04 2.0 mg/kg intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator (saline vehicle)

    Primary: WOMAC Pain Least Squares Mean Change from Baseline

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    End point title
    		 WOMAC Pain Least Squares Mean Change from Baseline
    End point description
    LSM Change from baseline in WOMAC pain subscore, LEVI-04 versus Placebo
    End point type
    Primary
    End point timeframe
    Baseline to Week 17
    End point values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Number of subjects analysed
    130
    130
    129
    129
    Units: Subjects
    130
    130
    129
    129
    Statistical analysis title
    		 LSM WOMAC Pain LEVI-04 0.3mg/kg
    Statistical analysis description
    Least Squares (LS) Mean Difference Change from Baseline to Week 17 in Standardized WOMAC Pain Subscale Score compared to placebo
    Comparison groups
    LEVI-04 0.3mg/kg v Placebo
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 -0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 WOMAC Pain LEVI-04 1mg/kg
    Statistical analysis description
    LSM Difference in WOMAC Pain, Change from Baseline to Week 17, LEVI-04 1mg/kg versus Placebo
    Comparison groups
    LEVI-04 1.0mg/kg v Placebo
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 -0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 WOMAC Pain LEVI-04 2mg/kg
    Statistical analysis description
    LSM Difference in WOMAC Pain, Change from Baseline to Week 17, LEVI-04 2mg/kg versus Placebo
    Comparison groups
    LEVI-04 2.0 mg/kg v Placebo
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 -0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23

    Secondary: WOMAC Physical Function

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    End point title
    		 WOMAC Physical Function
    End point description
    Least Squares Mean Change from Baseline versus Placebo
    End point type
    Secondary
    End point timeframe
    Baseline to Week 17
    End point values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Number of subjects analysed
    118
    119
    116
    113
    Units: Subjects
    118
    119
    116
    113
    Statistical analysis title
    		 WOMAC Physical Function, LEVI-04, 1mg/kg
    Statistical analysis description
    LSM Change from baseline to week 17 versus placebo
    Comparison groups
    LEVI-04 1.0mg/kg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 -0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 WOMAC Physical Function, LEVI-04, 0.3mg/kg
    Statistical analysis description
    Womac Physical function, Least Squares Mean change from baseline versus placebo
    Comparison groups
    LEVI-04 0.3mg/kg v Placebo
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 WOMAC Physical Function, LEVI-04, 2mg/kg
    Statistical analysis description
    WOMAC physical function, least squares mean difference change from baseline versus placebo
    Comparison groups
    LEVI-04 2.0 mg/kg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22

    Secondary: WOMAC Stiffness

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    End point title
    		 WOMAC Stiffness
    End point description
    Least Squares Mean Change from Baseline in Standardized WOMAC Stiffness Subscale Score versus placebo
    End point type
    Secondary
    End point timeframe
    Baseline to week 17 versus placebo
    End point values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Number of subjects analysed
    118
    119
    116
    113
    Units: Subjects
    118
    119
    116
    113
    Statistical analysis title
    		 WOMAC Stiffness LEVI-04 0.3mg/kg
    Statistical analysis description
    LSM Difference Mean Change from Baseline in Standardized WOMAC Stiffness Subscale versus placebo
    Comparison groups
    Placebo v LEVI-04 0.3mg/kg
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 WOMAC Stiffness LEVI-04 1mg/kg
    Statistical analysis description
    Mean Change from Baseline in Standardized WOMAC Stiffness Subscale Score versus placebo
    Comparison groups
    LEVI-04 1.0mg/kg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 -0.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 WOMAC Stiffness LEVI-04 2mg/kg
    Statistical analysis description
    LSM Difference Mean Change from Baseline in Standardized WOMAC Stiffness Subscale Score versus placebo
    Comparison groups
    LEVI-04 2.0 mg/kg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 -0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25

    Secondary: Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity

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    End point title
    		 Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity
    End point description
    LSM Difference Change from Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity versus placebo
    End point type
    Secondary
    End point timeframe
    Baseline to Week 17
    End point values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Number of subjects analysed
    111
    119
    113
    110
    Units: Subjects
    111
    119
    113
    110
    Statistical analysis title
    		 StEPP Change from Baseline LEVI 04 0.3mg/kg
    Statistical analysis description
    LSM Difference Change from Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity versus placebo
    Comparison groups
    LEVI-04 0.3mg/kg v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 StEPP Change from Baseline LEVI 04 1mg/kg
    Statistical analysis description
    LSM Difference Mean Change from Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity versus placebo
    Comparison groups
    LEVI-04 1.0mg/kg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 -0.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 StEPP Change from Baseline LEVI-04 2mg/kg
    Statistical analysis description
    LSM Difference Mean Change from Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity versus placebo
    Comparison groups
    LEVI-04 2.0 mg/kg v Placebo
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.76
         upper limit
    		 -0.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28

    Secondary: Patient Global Assessment (PGA)

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    End point title
    		 Patient Global Assessment (PGA)
    End point description
    LSM Difference Mean Change from Baseline in Patient Global Assessment (PGA) versus placebo
    End point type
    Secondary
    End point timeframe
    Baseline to Week 17
    End point values
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Number of subjects analysed
    118
    119
    116
    113
    Units: Subjects
    118
    119
    116
    113
    Statistical analysis title
    		 PGA Change from Baseline LEVI-04, 0.3mg/kg
    Statistical analysis description
    LSM Difference Change from Baseline in Patient Global Assessment (PGA)
    Comparison groups
    LEVI-04 0.3mg/kg v Placebo
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 PGA Change from Baseline LEVI-04, 1mg/kg
    Statistical analysis description
    Mean Change from Baseline in Patient Global Assessment (PGA)
    Comparison groups
    LEVI-04 1.0mg/kg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 PGA Change from Baseline LEVI-04, 2mg/kg
    Statistical analysis description
    LSM Difference Change from Baseline in Patient Global Assessment (PGA) versus placebo
    Comparison groups
    LEVI-04 2.0 mg/kg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 -0.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of signing the informed consent until the end of the study (week 30)
    Adverse event reporting additional description
    Adverse events were reported by participants, or via laboratory findings (blood, urine, ECG, vital signs) and imaging (X-rays of all large joints at baseline and week 20 and MRI of both knees at baseline and the target knee at week 20).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    LEVI-04 0.3mg/kg
    Reporting group description
    		 LEVI-04 0.3 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 1.0mg/kg
    Reporting group description
    		 LEVI-04 1.0 mg/kg intravenous infusion

    Reporting group title
    LEVI-04 2.0 mg/kg
    Reporting group description
    		 LEVI-04 2.0 mg/kg intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator (saline vehicle)

    Serious adverse events
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 130 (0.77%)
    3 / 129 (2.33%)
    3 / 129 (2.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tongue cancer metastatic
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 130 (0.77%)
    0 / 129 (0.00%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LEVI-04 0.3mg/kg LEVI-04 1.0mg/kg LEVI-04 2.0 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 129 (27.91%)
    36 / 130 (27.69%)
    58 / 129 (44.96%)
    62 / 129 (48.06%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 129 (3.10%)
    3 / 130 (2.31%)
    8 / 129 (6.20%)
    6 / 129 (4.65%)
         occurrences all number
    7
    3
    11
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 129 (8.53%)
    15 / 130 (11.54%)
    15 / 129 (11.63%)
    20 / 129 (15.50%)
         occurrences all number
    15
    19
    19
    24
    Back pain
         subjects affected / exposed
    3 / 129 (2.33%)
    5 / 130 (3.85%)
    8 / 129 (6.20%)
    3 / 129 (2.33%)
         occurrences all number
    3
    5
    9
    3
    Pain in extremity
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 130 (5.38%)
    5 / 129 (3.88%)
    5 / 129 (3.88%)
         occurrences all number
    3
    9
    5
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 129 (4.65%)
    8 / 130 (6.15%)
    13 / 129 (10.08%)
    13 / 129 (10.08%)
         occurrences all number
    7
    8
    14
    14
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 129 (3.10%)
    4 / 130 (3.08%)
    5 / 129 (3.88%)
    7 / 129 (5.43%)
         occurrences all number
    4
    4
    6
    7
    COVID-19
         subjects affected / exposed
    5 / 129 (3.88%)
    2 / 130 (1.54%)
    4 / 129 (3.10%)
    8 / 129 (6.20%)
         occurrences all number
    5
    2
    4
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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