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    Clinical Trial Results:
    A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients with Pain due to Osteoarthritis of the Knee

    Summary
    EudraCT number
    		 2018-004730-15
    Trial protocol
    		 GB   PL   BG   ES  
    Global end of trial date
    29 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Sep 2021
    First version publication date
    16 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R5069-OA-1849
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03956550
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, NY, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.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
    29 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of REGN5069 compared to placebo in subjects with pain due to radiographically-confirmed osteoarthritis (OA) of the knee who had a history of inadequate joint pain relief or intolerance to current analgesic therapy.
    Protection of trial subjects
    This clinical study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the International Council for Harmonisation (ICH) guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 May 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 51
    Country: Number of subjects enrolled
    Moldova, Republic of: 64
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    Ukraine: 41
    Country: Number of subjects enrolled
    Georgia: 47
    Worldwide total number of subjects
    259
    EEA total number of subjects
    56
    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)
    137
    From 65 to 84 years
    121
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 5 countries and 12 sites participated in enrollment. It consisted of screening period up to 30 days, followed by a 12-week randomized, double-blind, placebo-controlled treatment period, a 24-week follow-up period, and end-of-study phone call approximately 52 weeks after first dose. Study was terminated at 36 weeks..

    Pre-assignment
    Screening details
    		 A total of 259 subjects randomized in 1:1:1 ratio to receive REGN5069 at 100 mg IV Q4W or at 1000 mg IV Q4W, or matching placebo Q4W. Subjects received 3 fixed-dose IV infusions at baseline, week 4 & week 8. 171 subjects randomized to receive REGN5069 (86 subjects in 100 mg Q4W group & 85 in 1000 mg Q4W group) & 88 randomized to receive placebo.

    Period 1
    Period 1 title
    Overall Study (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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo intravenously every 4 weeks (Q4W)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching dose administered intravenously every 4 weeks (Q4W)

    Arm title
    		 REGN5069 100 mg Q4W
    Arm description
    		 Subjects received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    REGN5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV dose Q4W

    Arm title
    		 REGN5069 1000 mg Q4W
    Arm description
    		 Subjects received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    REGN5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV Q4W

    Number of subjects in period 1
    		Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Started
    88
    86
    85
    Completed
    18
    14
    15
    Not completed
    70
    72
    70
         Consent withdrawn by subject
    5
    5
    6
         Adverse event, non-fatal
    -
    1
    -
         Sponsor decision
    65
    66
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 100 mg Q4W
    Reporting group description
    		 Subjects received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 1000 mg Q4W
    Reporting group description
    		 Subjects received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Reporting group values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W Total
    Number of subjects
    		 88 86 85 259
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 51 45 41 137
        From 65-84 years
    		 36 41 44 121
        85 years and over
    		 1 0 0 1
    Age Continuous
    Full analysis set population (FAS): includes all randomized subjects
    Units: years
        arithmetic mean (standard deviation)
    		 63.5 ( 8.27 ) 63.9 ( 7.39 ) 64.7 ( 8.30 ) -
    Sex: Female, Male
    Full analysis set population (FAS): includes all randomized subjects
    Units: Subjects
        Female
    		 64 74 68 206
        Male
    		 24 12 17 53
    Race/Ethnicity, Customized
    Full analysis set population (FAS): includes all randomized subjects
    Units: Subjects
        White
    		 83 85 81 249
        Black or African American
    		 5 1 4 10
        Asian
    		 0 0 0 0
        American Indian or Alaska Native
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Not reported
    		 0 0 0 0
        Other
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Full analysis set population (FAS): includes all randomized subjects
    Units: Subjects
        Hispanic or Latino
    		 4 1 2 7
        Not Hispanic or Latino
    		 84 85 83 252
        Unknown or Not Reported
    		 0 0 0 0
    Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score equaled the sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. Here 'n' = number of evaluable subjects at the specific time point.
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    		 6.68 ( 1.257 ) 6.24 ( 1.203 ) 6.47 ( 1.150 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 100 mg Q4W
    Reporting group description
    		 Subjects received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 1000 mg Q4W
    Reporting group description
    		 Subjects received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Primary: Change from Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

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    End point title
    		 Change from Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
    End point description
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score = sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. Full Analysis Set (FAS) population included all randomized subjects; Here 'n' = number of evaluable subjects at a specific time point.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    80
    82
    Units: Scores on a scale
        least squares mean (standard error)
    -2.09 ( 0.188 )
    -2.37 ( 0.191 )
    -1.98 ( 0.190 )
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.689
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    REGN5069 100 mg Q4W v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2978
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change from Baseline to Week 12 in WOMAC Total Score

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    End point title
    		 Change from Baseline to Week 12 in WOMAC Total Score
    End point description
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score equaled the sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. FAS population included all randomized subjects; Here 'n' = number of evaluable subjects at the specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    80
    82
    Units: Scores on a scale
        least squares mean (standard error)
    -1.83 ( 0.177 )
    -2.15 ( 0.179 )
    -1.81 ( 0.181 )
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    Placebo v REGN5069 100 mg Q4W
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1973
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.942
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change from Baseline to Week 12 in WOMAC Physical Function Subscale Score

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    End point title
    		 Change from Baseline to Week 12 in WOMAC Physical Function Subscale Score
    End point description
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score equaled the sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. FAS population included all randomized subjects; Here 'n' = number of evaluable subjects at the specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    80
    82
    Units: Scores on a scale
        least squares mean (standard error)
    -1.74 ( 0.180 )
    -2.09 ( 0.183 )
    -1.75 ( 0.182 )
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9719
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    Placebo v REGN5069 100 mg Q4W
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1597
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change from Baseline to Week 12 in Patient Global Assessment (PGA) Score

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    End point title
    		 Change from Baseline to Week 12 in Patient Global Assessment (PGA) Score
    End point description
    The Patient Global Assessment of OA (PGA) is a subject-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). Full analysis set population (FAS): included all randomized subjects; Here 'n' = number of evaluable subjects at this time interval
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    80
    82
    Units: Scores on a scale
        least squares mean (standard error)
    -0.59 ( 0.076 )
    -0.75 ( 0.078 )
    -0.80 ( 0.078 )
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    Placebo v REGN5069 100 mg Q4W
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1365
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0604
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change from Baseline to Week 12 in WOMAC Stiffness Subscale Score

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    End point title
    		 Change from Baseline to Week 12 in WOMAC Stiffness Subscale Score
    End point description
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score equaled the sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. FAS population included all randomized subjects; Here 'n' = number of evaluable subjects at the specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    80
    82
    Units: Scores on a scale
        least squares mean (standard error)
    -1.70 ( 0.214 )
    -2.20 ( 0.217 )
    -1.88 ( 0.217 )
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5487
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    Placebo v REGN5069 100 mg Q4W
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0989
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Percentage of Subjects with ≥30% Improvement in WOMAC Pain Subscale Score

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    End point title
    		 Percentage of Subjects with ≥30% Improvement in WOMAC Pain Subscale Score
    End point description
    The WOMAC index has 24 parameters grouped in 3 subscales (pain-5 questions, physical function-17 questions & stiffness-2 questions), with 0-10 grading of each question. Each subscale score is summed up, divided by number of questions, & each is reported using Numerical Rating Scale (NRS) score 0-10. Total score equaled the sum of normalized subscale scores divided by 3 & reported using NRS score of 0-10. Higher scores equal worse pain, stiffness & functional limitations. FAS population included all randomized subjects; Here 'n' = number of evaluable subjects at the specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    88
    86
    85
    Units: Percentage of subjects
        number (not applicable)
    51.1
    58.1
    47.1
    Statistical analysis title
    		 Placebo, REGN5069 1000 mg Q4W
    Comparison groups
    Placebo v REGN5069 1000 mg Q4W
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5747
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Placebo, REGN5069 100 mg Q4W
    Comparison groups
    Placebo v REGN5069 100 mg Q4W
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3572
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) through End of Study

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    End point title
    		 Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) through End of Study
    End point description
    An adverse event (AE) is any untoward medical occurrence in a subject administered a study drug which may or may not have a causal relationship with the study drug. Treatment-emergent AEs (TEAEs) are AEs that developed or worsened during the treatment period. Safety Analysis Set (SAF): included all randomized subjects who received any study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 36
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    88
    85
    84
    Units: Number of events
        Non-Serious TEAEs
    78
    42
    55
        Serious TEAEs
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Imaging Abnormalities Consistent with Adjudicated Arthropathies through End of Study

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    End point title
    		 Number of Imaging Abnormalities Consistent with Adjudicated Arthropathies through End of Study
    End point description
    Adjudicated arthropathy is an umbrella term referring to Rapidly Progressive Osteoarthritis Type 1 (RPOA-1), Rapidly Progressive Osteoarthritis Type 2 (RPOA-2), subchondral insufficiency fractures (SIF) and osteonecrosis (ON) confirmed by an arthropathy adjudication committee. Safety Analysis Set (SAF): included all randomized subjects who received any study drug
    End point type
    Secondary
    End point timeframe
    Baseline to Week 36
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    88
    85
    84
    Units: Number of events
        Baseline Up to and Including Week 12 Visit
    1
    0
    0
        After Week 12 Visit, Up to and Including Week 36
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Presence of Anti-REGN5049 Antibody Development through End of Study

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    End point title
    		 Number of Subjects with Presence of Anti-REGN5049 Antibody Development through End of Study
    End point description
    Anti-Drug Antibody (ADA) Analysis Set: included all treated subjects who received any amount of study drug (active or placebo [safety analysis set (SAF)]) & had at least one non-missing anti-REGN5069 antibody result after first dose of study drug or placebo. ADA analysis set based on actual treatment received. Immunogenicity will be characterized by ADA responses & titers.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 36
    End point values
    		 Placebo REGN5069 100 mg Q4W REGN5069 1000 mg Q4W
    Number of subjects analysed
    84
    83
    82
    Units: Subjects
        Negative
    82
    83
    78
        Pre-Existing Immunoreactivity
    1
    0
    4
        Treatment-Boosted Response
    0
    0
    0
        Treatment-Emergent Response
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AE) and Serious Adverse Events (SAE) were collected from time of informed consent signature and then at each visit until the end of follow-up (week 36) for AEs and end of study (week 52) for SAEs. The study terminated early at 36 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 1000 mg IV Q4W
    Reporting group description
    		 Subjects received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Reporting group title
    REGN5069 100 mg IV Q4W
    Reporting group description
    		 Subjects received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)

    Serious adverse events
    		 Placebo REGN5069 1000 mg IV Q4W REGN5069 100 mg IV Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 88 (3.41%)
    0 / 84 (0.00%)
    3 / 85 (3.53%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo REGN5069 1000 mg IV Q4W REGN5069 100 mg IV Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 88 (54.55%)
    36 / 84 (42.86%)
    33 / 85 (38.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 88 (34.09%)
    20 / 84 (23.81%)
    19 / 85 (22.35%)
         occurrences all number
    64
    47
    36
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    10 / 88 (11.36%)
    0 / 84 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    15
    0
    7
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    9 / 88 (10.23%)
    8 / 84 (9.52%)
    3 / 85 (3.53%)
         occurrences all number
    14
    8
    4
    Arthralgia
         subjects affected / exposed
    6 / 88 (6.82%)
    7 / 84 (8.33%)
    9 / 85 (10.59%)
         occurrences all number
    7
    9
    17
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 88 (12.50%)
    7 / 84 (8.33%)
    4 / 85 (4.71%)
         occurrences all number
    14
    10
    4
    Urinary tract infection
         subjects affected / exposed
    9 / 88 (10.23%)
    5 / 84 (5.95%)
    4 / 85 (4.71%)
         occurrences all number
    14
    6
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2019
    Added end of study phone call to collect long-term information on subject status; Study duration, end of study definition were updated for accuracy; study analysis plan updated

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Oct 2020
    Study terminated early due to lack of efficacy for indication of pain for osteoarthritis.
    -

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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